(30 days)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."
The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients.
For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.
All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.
Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.
The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.
The provided document is a 510(k) Pre-market Notification for several Siemens ACUSON Diagnostic Ultrasound Systems, seeking clearance based on substantial equivalence to previously marketed devices. The document explicitly states that no new features, modifications, or changes were made to the hardware or software of the devices themselves. The entire submission focuses on an "expanded labeling" for lung ultrasound imaging, supported by existing clinical literature.
Therefore, the acceptance criteria and the study proving the device meets these criteria are not related to a new device or a new AI/algorithm feature being validated. Instead, it is about demonstrating that the existing, cleared devices can be marketed with expanded indications for use, supported by references to previously conducted tests and existing clinical literature.
Given this, I cannot provide information on:
- Reported device performance (as no new performance was claimed or tested)
- Sample size used for the test set or data provenance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Sample size for training set or how ground truth for training set was established
The document explicitly states: "clinical studies were not required to support substantial equivalence. The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature." and "There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission."
Below is a table summarizing the acceptance criteria and "device performance" in the context of this 510(k) submission, emphasizing that the "performance" here refers to the device meeting the previously established safety and effectiveness for its predicate indications, which is being extended to a new recognized clinical use case via labeling.
Description of Acceptance Criteria and Evidence for ACUSON Diagnostic Ultrasound Systems (K202683)
This 510(k) submission (K202683) by Siemens Medical Solutions, USA, Inc., is a Special 510(k). This type of submission is used when changes to a cleared device do not alter its fundamental scientific technology or intended use, but may expand its labeling or functionality within its established safety and effectiveness profile. In this specific case, the submission focuses on expanded labeling for Lung Ultrasound Imaging (LUS), utilizing the existing capabilities of the cleared ACUSON Diagnostic Ultrasound Systems and their associated transducers.
Crucially, the document states that no modifications were made to the software or hardware of the devices. Therefore, the "acceptance criteria" and "proof" are based on demonstrating substantial equivalence to previously cleared predicate devices and leveraging existing validation data for those predicates, rather than presenting new performance metrics for a novel algorithm or device.
1. Acceptance Criteria and Reported Device "Performance" (Meeting Substantial Equivalence)
| Acceptance Criteria (from 510(k) perspective) | Reported Device "Performance" / Justification for Meeting Criteria |
|---|---|
| Identical Intended Use/Indications for Use: The devices, with expanded labeling, align with the fundamental intended use of previously cleared predicate devices. | The Indications for Use statements for all listed ACUSON systems (Sequoia, SC2000, Freestyle, S1000/S2000/S3000, P200, P500, NX3/NX3 Elite) are presented as identical to their respective primary predicate devices, with the exception of the added use case for lung imaging explicitly mentioned in the "Indications for Use" section descriptions (e.g., "Abdominal (including liver, intra-operative)" for NX3 Elite). The core functionality and diagnostic purpose remain the same. The submission argues that lung ultrasound imaging falls within the scope of general diagnostic ultrasound. |
| Identical Technological Characteristics: The device hardware, software, and operating principles are unchanged from their predicate versions, ensuring safety and effectiveness. | The document explicitly states: "the subject devices are substantially equivalent to the cleared primary predicate devices and employs the same fundamental scientific technology and intended use/indications for use." Detailed comparison tables (Table 2 in the original document, not fully reproduced here due to length) consistently list "Identical" for all compared technological characteristics: Reusability, Duration of Use, Scientific Technology, Operating Principles, Type of Previously Cleared Transducers, Acoustic Outputs, Previously Cleared Imaging Modes, and Biocompatibility (ISO 10993-1). |
| Safety and Effectiveness: There are no new safety or effectiveness concerns introduced by the expanded labeling. | - Software Verification and Validation: The CRS (Customer Requirement Specifications) for each device were verified/validated during original development. No software/hardware modifications for this submission. - Standards Compliance: Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1 - 3.20 (DICOM). - Risk Management: Risk analysis (ISO 14971:2007) was performed on predicate devices, and mitigation controls were implemented. The expanded labeling does not impact these. - Cybersecurity: Cybersecurity measures are addressed and conform to requirements to prevent unauthorized access, modification, misuse, or denial of use. - Clinical Literature Support: The expanded labeling for Lung Ultrasound Imaging (LUS) is supported by clinical literature, indicating that the use of ultrasound for lung imaging is an established and safe practice. Clinical studies were not required for this 510(k) as the technology and operating principles are unchanged. |
2. Sample Size and Data Provenance for Test Set
- Test Set Description: Not applicable. For this Special 510(k), no new test set data for device performance was generated or presented. The submission relies on existing validation data for the predicate devices.
- Data Provenance: The underlying data for previously cleared predicate devices would have been generated through rigorous internal testing and validation processes during their initial development and clearance. The document implies that this data exists and supports the current device. The document explicitly states: "Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission."
3. Number, Qualifications, and Adjudication Method for Experts
- No new expert assessment: Not applicable for this Special 510(k). Since no new AI/algorithm features or changes to device performance were introduced, there was no independent expert review of a new test set for the purpose of this submission. The "ground truth" for the expanded labeling (Lung Ultrasound) is based on established clinical recognition and existing peer-reviewed literature.
- Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No new MRMC study: Not applicable. This submission does not involve a new AI or algorithm that would require an MRMC study to demonstrate human improvement with AI assistance.
5. Standalone (Algorithm Only) Performance Study
- No standalone algorithm: Not applicable. The submission is for diagnostic ultrasound systems, not a standalone algorithm. The core functionality is the ultrasound imaging, and the "expansion" is in the labeling for an existing modality.
6. Type of Ground Truth Used for Device Functions
- Existing Validated Performance: For the predicate devices, the ground truth and validation would have been established through a combination of:
- Direct measurement and engineering specifications: For image quality, acoustic output, and system performance.
- Clinical validation: Through various means including phantom studies, retrospective/prospective clinical data, and expert consensus for the initial indications.
- Clinical Literature/Consensus for Expanded Indication: For the new labeling related to Lung Ultrasound Imaging (LUS), the "ground truth" or justification is based on:
- Established clinical practice: Recognition within the medical community for the utility of ultrasound in lung assessment.
- Peer-reviewed studies and professional guidelines: As explicitly stated, the LUS labeling is "supported by clinical literature." This effectively implies that the medical community's consensus on the utility of LUS (as documented in such literature) serves as the "ground truth" for its clinical relevance.
7. Sample Size for Training Set
- No new training set: Not applicable. As no new AI/algorithm components were introduced or modified, there was no "training set" for the purpose of this specific 510(k) submission.
8. How Ground Truth for Training Set was Established
- No new training set: Not applicable.
{0}------------------------------------------------
October 15, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 22010 South East 51st Street ISSAQUAH WA 98029
Re: K202683
Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System. ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System, ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, LLZ, OIJ Dated: September 11, 2020 Received: September 15, 2020
Dear Ms. Dunbar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K202683
Device Name
ACUSON Sequoia Diagnostic Ultrasound System
Indications for Use (Describe)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
{3}------------------------------------------------
510 (k) Number (if known):
Device Name:
Intended Use:
ACUSON Sequoia Diagnostic Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | BMDC | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | ||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | ||||
| Adult Cephalic | P | P | P | P | P | BMDC | ||||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | ||||
| Transvaginal | P | P | P | P | P | BMDC | Volume Imaging | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | ||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{4}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 4V1 Phased Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | P | BMDC | ||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | ||||
| Small Organ(Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{5}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | DAX Curved Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMCD | ||||
| Abdominal | P | P | P | P | P | BMCD | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMCD | ||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{6}------------------------------------------------
510 (k) Number (if known):
Device Name:
5C1 Curved Array Transducer
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMCD | ||||
| Abdominal | P | P | P | P | P | BMCD | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMCD | ||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{7}------------------------------------------------
510 (k) Number (if known):
Device Name:
9C3 Curved Array Transducer
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMCD | |||||
| Abdominal | P | P | P | P | P | BMCD | |||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | BMCD | |||||
| Small Organ(Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | |||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{8}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | 18L6 Linear Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMCD | ||||
| Small Organ(Note 1) | P | P | P | P | P | BMCD | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{9}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 14L5 Linear Array Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMCD | ||||
| Small Organ(Note 1) | P | P | P | P | P | BMCD | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMCD | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
510 (k) Number (if known):
| Device Name: 10L4 Linear Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMCD | ||||
| Abdominal | P | P | P | P | P | BMCD | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMCD | ||||
| Small Organ(Note 1) | P | P | P | P | P | BMCD | ||||
| Neonatal Cephalic | P | P | P | P | P | BMCD | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMCD | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{11}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
9EC4 Endocavity Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMCD | ||||
| Transvaginal | P | P | P | P | P | BMCD | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{12}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 5V1 Phased Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | BMCD | |||
| Small Organ(Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMCD | ||||
| Cardiac | P | P | P | P | P | P | P | BMCD | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{13}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | 8V3 Phased Array Transducer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | BMCD | ||||||
| Intraoperative | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | BMCD | |||||
| Small Organ(Note 1) | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMCD | ||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |||||
| Trans-esophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{14}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | CW2 Continuous Wave TransducerUltrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | |||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{15}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 10V4 Phased Array Transducer | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Mode of Operation | ||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMCD | |||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMCD | |||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{16}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 18H6 Linear Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Note 1) | P | P | P | P | P | BMCD | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | |||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{17}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | CW5 Continuous Wave Transducer | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{18}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 7L2 Linear Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | BMCD | |||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | BMCD | |||||
| Small Organ(Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMCD | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{19}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 11M3 Curved Array Transducer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | BMCD | |||||
| Small Organ(Note 1) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMCD | |||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{20}------------------------------------------------
510 (k) Number (if known):
Device Name: 9VE4 Curved Endovaginal Mechanical 3D Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | N | N | N | N | BMCD | Volume Imaging | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K200707
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{21}------------------------------------------------
Indications for Use
510(k) Number (if known) K202683
Device Name
ACUSON SC2000 Diagnostic Ultrasound System
Indications for Use (Describe)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid atteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchromizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Dopler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
{22}------------------------------------------------
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{23}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202683
Device Name
ACUSON Freestyle Diagnostic Ultrasound System
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial),
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{24}------------------------------------------------
510 (k) Number (if known):
Device Name:
ACUSON Freestyle™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)(Note 2) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | |||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | |||||||
| Small Organ(Note 1) | P | P | P | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | |||||
| Musculo-skeletalSuperficial | P | P | P | P | P | |||||
| Other (specify) |
N = new indication; P = previously cleared by K162417, Blank = Not Claimed
Additional Comments:
Note 1
For example: breast, testes, thyroid, penis etc.
Note 2 B-mode and PWD mode or Color Doppler and PW mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{25}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | L8-3 Linear Array TransducerDiagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)(Note 2) | Other(Specify) | |
| Clinical Application | Mode of Operation | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | |||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | |||||||
| Small Organ(Note 1) | P | P | P | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | |||||||
| Musculo-skeletalSuperficial | P | P | P | |||||||
| Other (specify) |
N = new indication; P = previously cleared by K162417, Blank = Not Claimed
Additional Comments:
For example: breast, testes, thyroid, penis etc. Note 1
B-mode and PWD mode or Color Doppler and PW mode Note 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{26}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | L13-5 Linear Array TransducerDiagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)(Note 2) | Other(Specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | |||||||||
| Intraoperative | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | P | |||||||||
| Small Organ(Note 1) | P | P | P | |||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Trans-esophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | P | P | P | |||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | P | P | P | |||||||||
| Musculo-skeletalSuperficial | P | P | P | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by K162417, Blank = Not Claimed
Additional Comments:
For example: breast, testes, thyroid, penis etc. Note 1
Note 2 B-mode and PWD mode or Color Doppler and PW mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{27}------------------------------------------------
510 (k) Number (if known):
| Device Name:Intended Use: | L17-5 Linear Array TransducerDiagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)(Note 2) | Other(Specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | N | N | N | |||||||||
| Intraoperative | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | N | N | N | |||||||||
| Small Organ(Note 1) | N | N | N | |||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Trans-esophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | N | N | N | |||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | N | N | N | |||||||||
| Musculo-skeletalSuperficial | N | N | N | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by K162417, Blank = Not Claimed
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis etc.
Note 2 B-mode and PWD mode or Color Doppler and PW mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{28}------------------------------------------------
510 (k) Number (if known):
Device Name:
C5-2 Curvillinear Array Transducer
Diagnostic imaging or fluid flow analysis of the human body as follo
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)(Note 2) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | ||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | ||||||||
| Small Organ(Note 1) | P | P | P | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | P | ||||||||
| Musculo-skeletalSuperficial | P | P | P | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by K162417, Blank = Not Claimed
Additional Comments:
For example: breast, testes, thyroid, penis etc. Note 1
Note 2 B-mode and PWD mode or Color Doppler and PW mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{29}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202683
Device Name
S1000, S2000, S3000 Diagnostic Ultrasound Systems
Indications for Use (Describe)
The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for climical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Transducer Indications for Use are on the attached pages.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor and a person is not required to respond to a collection of
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid QMB number."
EF
{30}------------------------------------------------
510 (k) Number (if known): Device Name: Intended Use:
ACUSON S1000, S2000 and S3000 Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | P | P | P | P | P | P | BMDC | Note 2 | ||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ | P | P | P | P | P | P | BMDC | Note 1 | ||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | |||
| Adult Cephalic | P | P | P | P | P | P | BMDC | |||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | P | P | P | P | P | P | BMDC | |||
| Transrectal | P | P | P | P | P | BMDC | ||||
| Transvaginal | P | P | P | P | P | BMDC | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | BMDC | |||
| Other (specify)Neonatal Cardiac | P | P | P | P | P | P | BMDC |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{31}------------------------------------------------
510 (k) Number (if known): Device Name:
12L4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ | P | P | P | P | P | P | BMDC | Note 1 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | |||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{32}------------------------------------------------
510 (k) Number (if known): Device Name:
CW2 Probe for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | |||||||||
| Abdominal | P | |||||||||
| Intraoperative | P | Note 2 | ||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ | P | Note 1 | ||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | |||||||||
| Musculo-skeletalSuperficial | P | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{33}------------------------------------------------
510 (k) Number (if known): Device Name:
CW5 Probe for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | ||||||||||
| Abdominal | P | ||||||||||
| Intraoperative | P | Note 2 | |||||||||
| IntraoperativeNeurological | P | ||||||||||
| Pediatric | P | ||||||||||
| Small Organ | P | Note 1 | |||||||||
| Neonatal Cephalic | P | ||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | P | ||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | ||||||||||
| Musculo-skeletalSuperficial | P | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{34}------------------------------------------------
510 (k) Number (if known): Device Name:
EC9-4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | P | BMDC | ||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | P | P | P | P | P | BMDC | Note 1 | ||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | |||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | P | P | P | P | P | BMDC | |||||
| Transvaginal | P | P | P | P | P | BMDC | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{35}------------------------------------------------
510 (k) Number (if known): Device Name:
MC9-4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | BMDC | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | BMDC | Note 1 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | ||||
| Transvaginal | P | P | P | P | P | BMDC | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{36}------------------------------------------------
510 (k) Number (if known): Device Name:
9L4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | ||||
| Small Organ | P | P | P | P | P | BMDC | Note 1 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | ||||
| Adult Cephalic | P | P | P | P | P | BMDC | ||||
| Cardiac | P | P | P | P | P | BMDC | ||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | ||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{37}------------------------------------------------
510 (k) Number (if known): Device Name:
14L5 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 1 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | |||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{38}------------------------------------------------
510 (k) Number (if known): Device Name:
4P1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | |||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{39}------------------------------------------------
510 (k) Number (if known):
Device Name:
6C2 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{40}------------------------------------------------
510 (k) Number (if known):
Device Name:
4C1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 2 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{41}------------------------------------------------
510 (k) Number (if known): Device Name:
6C1 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 2 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{42}------------------------------------------------
510 (k) Number (if known):
Device Name:
8C3 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | BMDC | |||||
| Abdominal | P | P | P | P | P | BMDC | |||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | |||||
| Small Organ | P | P | P | P | P | BMDC | Note 2 | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{43}------------------------------------------------
510 (k) Number (if known):
Device Name:
4V1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | BMDC | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{44}------------------------------------------------
510 (k) Number (if known):
Device Name:
10V4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | |||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{45}------------------------------------------------
510 (k) Number (if known): _
Device Name:
14L5 SP Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Indications For Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | P | P | P | P | P | P | BMDC | Note 2 | |||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | Note 1 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | ||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{46}------------------------------------------------
510 (k) Number (if known):
Device Name:
7CF2 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | BMDC | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{47}------------------------------------------------
510 (k) Number (if known):
Device Name:
7CF1 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | P | P | P | P | P | BMDC | ||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{48}------------------------------------------------
510 (k) Number (if known):
Device Name:
9EVF4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | ||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | BMDC | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{49}------------------------------------------------
510 (k) Number (if known): Device Name:
V5Ms Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | BMDC | |||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{50}------------------------------------------------
510 (k) Number (if known): Device Name:
18L6 HD Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | P | P | P | P | P | P | P | BMDC | Note 1 | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | BMDC | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P | BMDC | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{51}------------------------------------------------
510 (k) Number (if known): Device Name:
8V3 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | BMDC | ||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | BMDC | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | BMDC | ||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | BMDC | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify)Neonatal Cardiac | P | P | P | P | P | P | P | BMDC |
N = new indication; P = previously cleared by FDA K162243 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{52}------------------------------------------------
510 (k) Number (if known): Device Name:
4V1c Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | P | P | P | P | P | P | BMDC | Note 2 | ||
| IntraoperativeNeurological | P | P | P | P | P | P | BMDC | |||
| Pediatric | P | P | P | P | P | P | BMDC | |||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | |||
| Cardiac | P | P | P | P | P | P | BMDC | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify)Neonatal Cardiac | P | P | P | P | P | P | BMDC |
N = new indication; P = previously cleared by FDA K162243 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{53}------------------------------------------------
510 (k) Number (if known): Device Name:
EV-8C4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | |||
| Abdominal | P | P | P | P | P | P | BMDC | |||
| Intraoperative | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | BMDC | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{54}------------------------------------------------
510 (k) Number (if known):
Device Name:
V7MTransducer for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) * | HarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P | ||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | ||
| Trans-esophageal | P | P | P | P | P | P | P | P | P | ||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal(Superficial) | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color, Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{55}------------------------------------------------
510 (k) Number (if known): Device Name:
AcuNav 8F Ultrasound Catheter for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) * | Other:HarmonicImaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(Vascular) | ||||||||||
| Intraoperative(Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | P | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | P | ||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{56}------------------------------------------------
510 (k) Number (if known): Device Name:
AcuNav 10F Ultrasound Catheter for use with ACUSON S1000, S2000 and S3000 Ultrasound Systems
Intended Use:
The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) * | Other:HarmonicImaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(Vascular) | ||||||||||
| Intraoperative(Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | P | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | P | ||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K162243
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{57}------------------------------------------------
Indications for Use
510(k) Number (if known)
K202683
Device Name ACUSON P200 Diagnostic Ultrasound System
Indications for Use (Describe)
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{58}------------------------------------------------
510 (k) Number (if known):
Device Name:
ACUSON P200 Diagnostic Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows.
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | BMDC | ||
| Abdominal | P | P | P | P | P | BMDC | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | P | BMDC | |
| Small Organ (Note 1) | P | P | P | P | P | BMCD | ||
| Neonatal Cephalic | P | P | P | P | P | BMCD | ||
| Adult Cephalic | ||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | P | P | P | P | P | P | BMCD | |
| Transrectal | P | P | P | P | P | BMCD | ||
| Transvaginal | P | P | P | P | P | BMCD | ||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | P | P | P | P | P | P | BMCD | |
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067; K180039; K187357
Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{59}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
4V1 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | BMDC | ||
| Abdominal | P | P | P | P | P | BMDC | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMDC | ||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 1 Note 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{60}------------------------------------------------
510 (k) Number (if known):
Device Name:
5V1 Phased Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | P | BMCD | |
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{61}------------------------------------------------
510 (k) Number (if known):
Device Name:
8V3 Phased Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | BMCD | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | P | BMCD | |
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{62}------------------------------------------------
510 (k) Number (if known):
Device Name:
10V4 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | BMCD | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMCD | ||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | BMCD | ||
| Adult Cephalic | ||||||||
| Cardiac | P | P | P | P | P | P | BMCD | |
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K183575
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{63}------------------------------------------------
510 (k) Number (if known):
Device Name:
CW2 Continuous Wave Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | |||||||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | P | |||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K183575
Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{64}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
CW5 Continuous Wave Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | |||||||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | P | |||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K183575
Note 1 For example: Breast, Thyroid, Testis Note 2 For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{65}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
10L4 Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | BMCD | |
| Abdominal | P | P | P | P | P | P | BMCD | |
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | P | BMCD | |
| Small Organ (Note 1) | P | P | P | P | P | BMCD | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | P | P | P | P | P | P | BMCD | |
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1 For example: Breast, Thyroid, Testis Note 2 For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{66}------------------------------------------------
510 (k) Number (if known):
Device Name:
14L5 Linear Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMCD | ||
| Small Organ (Note 1) | P | P | P | P | P | BMCD | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | P | P | P | P | P | BMCD | ||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{67}------------------------------------------------
510 (k) Number (if known):
Device Name:
18L6 Linear Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMCD | ||
| Small Organ (Note 1) | P | P | P | P | P | BMCD | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMCD | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{68}------------------------------------------------
510 (k) Number (if known):
Device Name:
5C1 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | BMCD | ||
| Abdominal | P | P | P | P | P | BMCD | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMCD | ||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{69}------------------------------------------------
510 (k) Number (if known):
Device Name:
9C3 Curved Array Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | BMCD | ||
| Abdominal | P | P | P | P | P | BMCD | ||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | P | P | P | P | P | BMCD | ||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMCD | ||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{70}------------------------------------------------
510 (k) Number (if known):
Device Name:
9EC4 Endocavity Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | ||||||||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | ||||||||
| Transrectal | P | P | P | P | P | BMCD | ||
| Transvaginal | P | P | P | P | P | BMCD | ||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K180067
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{71}------------------------------------------------
510 (k) Number (if known):
Device Name:
V5Ms Multiplane TEE Transducer
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intraoperative | ||||||||
| IntraoperativeNeurological | ||||||||
| Pediatric | ||||||||
| Small Organ (Note 1) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Trans-esophageal | P | P | P | P | P | P | BMCD | |
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Intravascular | ||||||||
| Peripheral vessel(Note 2) | ||||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | ||||||||
| Musculo-skeletalSuperficial | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K183575
Note 1
Note 2
For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{72}------------------------------------------------
Indications for Use
510(k) Number (if known)
K202683
Device Name ACUSON P500 Ultrasound System
Indications for Use (Describe)
The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."
The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{73}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
ACUSON P500™ Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | |
| Abdominal | P | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | |
| Intra-operative(Note 6) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Neonatal Cephalic | N | ||||||||
| Adult Cephalic | N | ||||||||
| Trans-rectal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Trans-vaginal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Musculo-skel.(Superfic) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Intra -vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2, 4, 6, 7, 8, 10, 12, 16 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | BMDC | Note 2, 4, 6, 7, 10, 12, 16 |
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-Cardiac | N | N | N | N | N | N | BMDC | Note 2, 4, 10, 12, 14, 15, 16 | |
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | N | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 |
| Vessel | Other (Specify) |
N = new indication; P = previously cleared
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 2 of 16
{74}------------------------------------------------
510(k) Number (if known):
| Device Name: | P4-2 Phased Array Transducer for use with:ACUSON P500™ Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2, 4, 12,16 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2, 4, 12,16 | ||
| Intra-operative | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | |||||||||
| SmallOrgan(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | ||||||||||
| Musculo-skel.(Superfic) | ||||||||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2, 4, 6, 7, 8, 10, 12, 16 | ||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| PeripheralVessel | Peripheral vessel(Note 5) | |||||||||
| Other (Specify) |
N = new indication; P = previously cleared K150050
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 3 of 16
{75}------------------------------------------------
510(k) Number (if known):
Device Name: CH5-2 Curved Array Transducer for use with:
ACUSON P500™ Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Abdominal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel(Note 5) | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | |
| Vessel | Other (Specify) |
N = new indication; P = previously cleared K150050
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 4 of 16
{76}------------------------------------------------
510(k) Number (if known):
| Device Name: | VF10-5 Linear Array Transducer for use with:ACUSON P500™ Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| Other(Track1Only) | Specific(Tracks 1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | |||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |||
| Musculo-skel.(Superfic) | ||||||||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | Peripheral vessel(Note 5) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared K150050
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
- 510(k)_
{77}------------------------------------------------
510(k) Number (if known):
Device Name: EC9-4 Curved Array Transducer for use with:
ACUSON P500™ Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Trans-vaginal | P | P | P | P | P | BMDC | Note 2, 3, 4, 11, 12, 16 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel(Note 5) | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared K150050
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 6 of 16
{78}------------------------------------------------
| 510(k) Number (if known): |
|---|
| --------------------------- |
Device Name:
Intended Use:
VF13-5 Linear Transducer for use with:
ACUSON P500™ Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1&3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | P | P | P | P | P | BMDC | Note 2, 3, 4 , 9, 11, 12, 13, 16 | ||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel(Note 5) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| Other (Specify) |
N = new indication; P = previously cleared K150050
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 7 of 16
{79}------------------------------------------------
510(k) Number (if known):
VF16-5 Transducer for use with:
ACUSON P500™ Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel(Note 5) | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 8 of 16
{80}------------------------------------------------
510(k) Number (if known):
Device Name:
P8-4 Transducer for use with:
ACUSON P500™ Ultrasound System
Intended Use:
C-4 Transducer for use With:
CUSON P500™ Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2, 4, 12, 16 | ||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| SmallOrgan(Note 1) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2, 4, 6, 7, 10, 12, 16 | |
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel(Note 5) | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by K141846, K161787
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 9 of 16
{81}------------------------------------------------
510(k) Number (if known):
Device Name:
0-5v Transducer for use with:
Intended Use:
L10-5v Transducer for use with:
ACUSON P500™ Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | ||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel(Note 5) | P | P | P | P | P | BMDC | Note 2, 3, 4, 9, 11, 12, 13, 16 | |
| Vessel | Other (Specify) |
N = new indication; P = previously cleared K161787
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 10 of 16
{82}------------------------------------------------
510(k) Number (if known):
Device Name:
CW2 Transducer for use with:
ACUSON P500™ Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | P | ||||||||
| Adult Cephalic | P | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel(Note 5) | P | |||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 11 of 16
{83}------------------------------------------------
510(k) Number (if known):
Device Name:
CW5 Transducer for use with:
ACUSON P500™ Ultrasound System
Intended Use:
CUSON P500™ Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | P | ||||||||
| Adult Cephalic | P | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | Cardiac Pediatric | P | |||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel(Note 5) | P | |||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
- 510(k)_
{84}------------------------------------------------
510(k) Number (if known):
| 510(k) Number (if known): | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Device Name: | AcuNav 8F Transducer for use with:ACUSON P500™ Diagnostic Ultrasound System | |||||||||
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| Other( Track1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | |||||||||
| SmallOrgan(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | ||||||||||
| Musculo-skel.(Superfic) | ||||||||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2, 4, 10, 12, 14, 16 | ||
| Other (Specify) | ||||||||||
| Peripheral vessel |
Other (Specify) N = new indication; P = previously cleared K141846
(Note 5)
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Peripheral
Vessel
Page 13 of 16
{85}------------------------------------------------
510(k) Number (if known):
AcuNav 10F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.)
Other (Specify) N = new indication; P = previously cleared K141846
Other (Specify) Peripheral vessel
(Note 5)
Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac
Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
b
b
BMDC
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
b
b
b
b
- 510(k)_
Cardiac
Peripheral
Vessel
Note 2, 4, 10, 12, 14, 16
{86}------------------------------------------------
510(k) Number (if known):
Soundstar 10F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined
| Other( Track1Only) | Specific(Tracks1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2, 4, 10, 12, 14, 15, 16 | |
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel(Note 5) | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 15 of 16
{87}------------------------------------------------
510(k) Number (if known): Soundstar eco 8F Transducer for use with:
ACUSON P500™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac b b b b b b BMDC Note 2, 4, 10, 12, 14, 15, 16 Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify)
N = new indication; P = previously cleared K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 15 of 16
{88}------------------------------------------------
510(k) Number (if known):
Soundstar eco 10F Transducer for use with: Device Name: ACUSON P500™ Diagnostic Ultrasound System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac b b b b b b BMDC Note 2, 4, 10, 12, 14, 15, 16 Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify)
N = new indication; P = previously cleared K141846
| Note 1 | For example: breast, testes, thyroid, prostate, etc. |
|---|---|
| Note 2 | Dynamic TCE Technology |
| Note 3 | Advanced SieClear |
| Note 4 | eSielmage |
| Note 5 | For example: abdominal, vascular (upper and lower) |
| Note 6 | Stress Echo |
| Note 7 | eSieMeasure |
| Note 8 | eSieScan |
| Note 9 | AHP |
| Note 10 | DTI |
| Note 11 | Panoramic 2D Imaging (SieScape) |
| Note 12 | Clarify VE |
| Note 13 | Needle Visualization |
| Note 14 | Intracardiac Echocardiography (ICE) Imaging |
| Note 15 | CARTOSOUND Communication |
| Note 16 | Probe Saver |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 16 of 16
{89}------------------------------------------------
Indications for Use
510(k) Number (if known) K202683
Device Name
ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System
Indications for Use (Describe)
For ACUSON NX3
The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
For ACUSON NX3 Elite
The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{90}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{91}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use: ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other(Specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | ||||
| Abdominal | P | P | P | P | P | P | ||||
| Intra-operative(Note 2) | P | P | P | P | P | P | ||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | P | |||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | |||
| Neonatal Cephalic | P | P | P | P | P | P | ||||
| Adult Cephalic | P | P | P | P | P | P | P | |||
| Trans-rectal | P | P | P | P | P | P | ||||
| Trans-vaginal | P | P | P | P | P | P | ||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | ||||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | ||||
| Intra -vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | ||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | P | P | P | P | P | P | P | |||
| Intra-Cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |||
| Vessel | Other (Specify) | |||||||||
| N = new indication; P = previously cleared by (K173957) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 1 of 19
{92}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use: ACUSON NX3TM Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | P | ||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | ||
| Neonatal Cephalic | P | P | P | P | P | P | |||
| Adult Cephalic | P | P | P | P | P | P | |||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | |||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | |||
| Intra -vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | |||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | ||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by (K173957)
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 2 of 19
{93}------------------------------------------------
510(k) Number (if known):
| Device Name: | CH5-2 Transducer for use with:ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic UltrasoundSystem | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| Other( Track 1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | ||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | |||||
| Abdominal | P | P | P | P | P | P | |||||
| Intra-operative(Note 2) | |||||||||||
| Intra-operative(Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Fetal | Pediatric | P | P | P | P | P | P | ||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph.(non-Card.) | |||||||||||
| Musculo-skel.(Convent.) | |||||||||||
| Musculo-skel.(Superfic) | |||||||||||
| Intra-vascular | |||||||||||
| Other(Specify) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Intra-vascular | |||||||||||
| (Cardiac) | |||||||||||
| Trans-esophageal(Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (Specify) | |||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | ||||
| Vessel | Other (Specify) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 3 of 19
{94}------------------------------------------------
510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Other( Track 1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | ||||
| Intra-operative(Note 2) | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | P | |||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | ||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | ||||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | ||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |||
| PeripheralVessel | Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 4 of 19
{95}------------------------------------------------
510(k) Number (if known):
Device Name:
VF12-4 Linear Array Transducer for use with:
VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | ||
| SmallOrgan(Note 1) | P | P | P | P | P | P | |||
| Neonatal Cephalic- NX3 Elite only | P | P | P | P | P | P | |||
| Adult Cephalic | P | P | P | P | P | P | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | |||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | |||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | ||
| Other (Specify) | |||||||||
| N = new indication; P = previously cleared by (K173957) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 5 of 19
{96}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
EC10-5w Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks 1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | ||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | P | P | P | P | P | P | |||
| Neonatal Cephalic | P | P | P | P | P | P | |||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 6 of 19
{97}------------------------------------------------
510(k) Number (if known):
Device Name:
EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | PediatricSmallOrgan(Note 1) | P | P | P | P | P | P | ||
| Neonatal Cephalic- NX3 Elite Only | P | P | P | P | P | P | |||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
E 3 Combined modes are D/W, D/C, D/I WD, D/I Power, D/CI WD or C/WD, D/CI/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 7 of 19
{98}------------------------------------------------
510(k) Number (if known):
CW2 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac | Cardiac Adult | P | |||||||
| Cardiac Pediatric | P | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N = new indication; P = previously cleared by (K173957) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 8 of 19
{99}------------------------------------------------
510(k) Number (if known):
CW5 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Other(Track1Only) | Specific(Tracks1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging& Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative(Note 2) | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| SmallOrgan(Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | ||||||||||
| Musculo-skel.(Superfic) | ||||||||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac | Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (Specify) | ||||||||||
| N = new indication; P = previously cleared by (K173957) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 9 of 19
{100}------------------------------------------------
510(k) Number (if known):
Device Name:
P4-2 Phased Sector Array Transducer for use with:
P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track 1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | P | ||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | ||
| Neonatal Cephalic– NX3 Elite Only | P | P | P | P | P | P | |||
| Adult Cephalic | P | P | P | P | P | P | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N = new indication; P = previously cleared by (K173957) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 10 of 19
{101}------------------------------------------------
510(k) Number (if known):
VF16-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | ||||
| Intra-operative(Note 2) | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | |||
| SmallOrgan(Note 1) | P | P | P | P | P | P | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | ||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | ||||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | ||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 11 of 19
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
{102}------------------------------------------------
510(k) Number (if known):
VF13-5sp Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | ||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative(Note 2) | P | P | P | P | P | P | |||||
| Intra-operative(Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Fetal | Pediatric | P | P | P | P | P | P | ||||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | |||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph.(non-Card.) | |||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | |||||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | |||||
| Intra-vascular | |||||||||||
| Other(Specify) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Intra-vascular(Cardiac) | |||||||||||
| Trans-esophageal(Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (Specify) | |||||||||||
| Peripheral | Peripheral vessel(Note 1) | P | P | P | P | P | P | ||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular, small parts
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 12 of 19
{103}------------------------------------------------
510(k) Number (if known):
| Device Name: | C8F3 Transducer for use with:ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| Other( Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| SmallOrgan(Note 1) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | |||||||||
| PeripheralVessel | Other (Specify) |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 13 of 19
{104}------------------------------------------------
510(k) Number (if known):
C8-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
HETEROCYCLES
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track 1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | ||
| SmallOrgan(Note 1) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | |||
| Adult Cephalic | P | P | P | P | P | P | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | ||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 14 of 19
{105}------------------------------------------------
510(k) Number (if known):
P8-4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
Device Name:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | P | P | P | P | P | P | P | |
| SmallOrgan(Note 1) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 15 of 19
{106}------------------------------------------------
510(k) Number (if known):
11L4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Other( Track1Only) | Specific(Tracks1I&3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging& Other | Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | ||||
| Intra-operative(Note 2) | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | ||||
| SmallOrgan(Note 1) | P | P | P | P | P | P | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | ||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skel.(Convent.) | P | P | P | P | P | P | ||||
| Musculo-skel.(Superfic) | P | P | P | P | P | P | ||||
| Intra-vascular | ||||||||||
| Other(Specify) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intra-vascular(Cardiac) | ||||||||||
| Trans-esophageal(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |||
| Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)
Page 16 of 19
{107}------------------------------------------------
510(k) Number (if known):
10MC3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track 1Only) | Specific(Tracks11& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)
Page 17 of 19
{108}------------------------------------------------
510(k) Number (if known):
BP10-3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other( Track 1Only) | Specific(Tracks1I&3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card.) | |||||||||
| Musculo-skel.(Convent.) | |||||||||
| Musculo-skel.(Superfic) | |||||||||
| Intra-vascular | |||||||||
| Other(Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)
Page 18 of 19
{109}------------------------------------------------
510(k) Number (if known):
V5Ms Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation Other Specific
(Tracks1I& 3) Color Power Combined
(Note 3) Other (Track1 B M PWD CWD Doppler Doppler (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Note 2) Intra-operative (Neuro) Laparoscopic Fetal Pediatric SmallOrgan Imaging & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal P P P P P P b (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify)
N = new indication; P = previously cleared by (K173957)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)
Page 19 of 19
{110}------------------------------------------------
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c)
| Date prepared: | September 11, 2020 – Date Updated: Oct. 13, 2020 |
|---|---|
| Part 1. Sponsor: | Siemens Medical Solutions USA, Inc.,Ultrasound Division |
| 22010 South East 51st StreetIssaquah, WA 98029, USA | |
| Contact Person: | Christine Dunbar |
| Senior Regulatory Affairs | |
| Siemens Medical Solutions USA, Inc.,Ultrasound Division | |
| 685 East Middlefield Road | |
| Mountain View, California 94043 | |
| Email: Christine.dunbar@siemens.com | |
| Tel: (925) 374-2045 | |
| Part 2. DeviceName: | ACUSON Sequoia Diagnostic Ultrasound SystemACUSON SC2000 Diagnostic Ultrasound SystemACUSON Freestyle Diagnostic Ultrasound SystemACUSON S1000, S2000, S3000 Diagnostic Ultrasound SystemsACUSON P200 Diagnostic Ultrasound SystemACUSON P500 Diagnostic Ultrasound SystemACUSON NX3, NX3 Elite Diagnostic Ultrasound System |
| Common Name: | Diagnostic ultrasound system and transducers |
| ClassificationName: | Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer, Diagnostic Intravascular Catheter, Picture Archiving and Communications System, Biopsy Needle Guide Kit |
| Classification: | Regulatory Class: IIReview Category: Tier II |
| Classification Panel | Radiology and Cardiology |
| CFR Section | 21 CFR §892.1550, §892.1560, §892.1570, §870.1200,§892.2050, §892.1560. |
| Product Code | 90-ΙΥΝ, 90-IYO, 90-ITX, 90-OBJ, 90-LLZ, 90-OIJ |
{111}------------------------------------------------
Legal Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Division 22010 South East 51st Street Issaquah, WA 98029, USA
Part 3. Legally Marketed Predicate Devices
The Siemens ACUSON Diagnostic Ultrasound systems as described in this Special 510(k) submission is substantially equivalent to the company's legally marketed devices as represented below:
| Primary Predicate DeviceName | 510(k) Clearance # / Date | Product Code |
|---|---|---|
| ACUSON Sequoia | K201462 / June 24th, 2020 | IYN, IYO, ITX, OIJ |
| ACUSON SC2000 | K200585 / April 22, 2020 | IYN, IYO, ITX, OBJ, LLZ |
| ACUSON Freestyle | K200644 / April 10, 2020 | IYN, IYO, OIJ, ITX |
| ACUSON S1000, S2000,S3000 | K172162 / Aug. 16, 2017 | IYN, IYO, ITX, OBJ |
| ACUSON P200 | K191922 / Aug. 15, 2019 | IYN, IYO, ITX |
| ACUSON P500 | K163396 / Jan. 04, 2017 | IYN, IYO, ITX, OBJ |
| ACUSON NX3, NX3 Elite | K192835 / Oct. 22, 2019 | IYN, IYO, ITX |
| Secondary PredicateDevice NameACUSON Juniper | K201130 / May 26, 2020 | IYN, IYO, ITX, OIJ |
| Reference PredicatePhilips Affiniti™ DiagnosticUltrasound System Series | K201012 / May 1, 2020 | IYN, IYO, ITX, QIH |
Part 4. Device Description for Representative Device, ACUSON Sequoia:
The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes,
{112}------------------------------------------------
Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.
All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.
Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.
The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.
Part 5. Intended Use and Indications for Use Statements:
K202683
ACUSON Sequoia Diagnostic Ultrasound System
Indications for Use:
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
K202683
ACUSON SC2000 Diagnostic Ultrasound System
Indications for Use:
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the
Siemens Medical Solutions USA. Inc. Ultrasound Division
{113}------------------------------------------------
heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic
capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
K202683
ACUSON Freestyle Diagnostic Ultrasound System
Indications for Use:
The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions:
Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
K202683
ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems Indications for Use: Siemens Medical Solutions USA, Inc.
Ultrasound Division
{114}------------------------------------------------
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and neonatal cardiac } and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging".
The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heard of adult and pediatric patients.
K202683
ACUSON P200 Diagnostic Ultrasound System
Indications for Use:
The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculations packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
K202683
ACUSON P500 Ultrasound System
Indications for Use:
The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.
{115}------------------------------------------------
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Imaging". The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
K202683
ACUSON NX3 Diagnostic Ultrasound System
ACUSON NX3 Elite Diagnostic Ultrasound System
Indications for Use:
For ACUSON NX3
The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Organ), Neonatal Cephalic, Adult Cephalic. Transcranial. OB/GYN. Pelvic. Neonatal. Cardiac. Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. For ACUSON NX3 Elite
The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac (including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task force, Endorsed by the Society for Vascular Medicine".
{116}------------------------------------------------
Part 6. Technological Characteristics as compared to Predicate Device
The subject devices are substantially equivalent to the cleared primary predicate devices and employs the same fundamental scientific technology and intended use/indications for use. The Intended Use and Indications for Use are not specifically intended to be modified, however the labeling is expanded to include Lung ultrasound imaging by use of marketing materials, training materials, references to clinical literature and instructions for the user to enable the creation of ultrasound protocols called Presets.
User labeling for the subject devices have been expanded to include information about lung ultrasound imaging, based on established methods or the latest professional society guidelines, for patients with coronavirus disease 2019 (COVID-19).
A comparison table as Table 2 is provided beginning on the following page:
| ACUSON Sequoia Diagnostic Ultrasound System K# Pending (Subject Device) | ACUSON Sequoia Diagnostic Ultrasound System K201462 (Predicate Device) | Comparison | |
|---|---|---|---|
| Standard Feature | |||
| Indications for Use | The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and | The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and | Identical |
| StandardFeature | ACUSON SequoiaDiagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SequoiaDiagnostic UltrasoundSystemK201462(Predicate Device) | Comparison |
| Peripheral Vascularapplications. | Peripheral Vascularapplications. | ||
| The system also providesthe ability to measureanatomical structures forfetal, abdominal,pediatric, small organ,cardiac, transrectal,transvaginal, peripheralvessel, musculoskeletaland calculation packagesthat provide informationto the clinician that maybe used adjunctively withother medical dataobtained by a physicianfor clinical diagnosispurposes. | The system also providesthe ability to measureanatomical structures forfetal, abdominal,pediatric, small organ,cardiac, transrectal,transvaginal, peripheralvessel, musculoskeletaland calculation packagesthat provide informationto the clinician that maybe used adjunctively withother medical dataobtained by a physicianfor clinical diagnosispurposes. | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operatingprinciples | Diagnostic ultrasounduses high-frequency(above the audible range)sound waves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into thebody. Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer at | Diagnostic ultrasounduses high-frequency(above the audible range)sound waves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into thebody. Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer at | Identical |
Table 2: Comparison of Technological Characteristics with the Predicate Device
{117}------------------------------------------------
{118}------------------------------------------------
ACUSON Sequoia ACUSON Sequoia Diagnostic Ultrasound Diagnostic Ultrasound Standard Svstem System Comparison Feature K# Pending K201462 (Subject Device) (Predicate Device) tissue density, for tissue density, for example, at the example, at the border of two organs in border of two organs in the body. These return the body. These return provide provide signals signals information about the information about the acoustic properties of the acoustic properties of the tissue. The time to receive tissue. The time to receive the echo in microseconds the echo in microseconds indicates a indicates a distance into the body. distance into the body. Structures furthest from Structures furthest from the transducer surface the transducer surface require more time to require more time to return a signal than return a signal than structures closer to the structures closer to the transducer surface. The transducer surface. The strength and position of strength and position of each signal indicates a each signal indicates a point of varying intensity point of varying intensity (brightness). (brightness). The The distances and intensities distances and intensities are processed -and are are are processed and displayed on a screen to displayed on a screen to form a two-dimensional form a two-dimensional (2D) (2D) image. image. Curved Array Transducer Curved Array Transducer Linear Array Transducer Linear Array Transducer Type of Phased Array Transducer Phased Array Transducer Previously Continuous Wave Continuous Wave Identical cleared Transducers Transducers Transducers Curved Array Mechanical Curved Array Mechanical 3D Transducer 3D Transducer Acoustic Yes Yes Identical Outputs Within Range? Previously cleared Yes Yes Identical Imaging Modes?
ACUSON DIAGNOSTIC ULTRASOUND SYSTEMS UPDATE Special 510(k)
Siemens Medical Solutions USA, Inc. Ultrasound Division
{119}------------------------------------------------
| StandardFeature | ACUSON SequoiaDiagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SequoiaDiagnostic UltrasoundSystemK201462(Predicate Device) | Comparison |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| ACUSON SC2000 | ACUSON SC2000 | ||
|---|---|---|---|
| Diagnostic Ultrasound | Diagnostic Ultrasound | ||
| Standard Feature | System | System | Comparison |
| K# Pending | K200585 | ||
| (Subject Device) | (Predicate Device) | ||
| The SC2000 ultrasound | The SC2000 ultrasound | ||
| imaging system is intended | imaging system is intended | ||
| for the following | for the following | ||
| applications: | applications: | ||
| Cardiac,Neo-natal and Fetal | Cardiac,Neo-natal and Fetal | ||
| Cardiac, Pediatric, | Cardiac, Pediatric, | ||
| Transesophageal, Adult | Transesophageal, Adult | ||
| Cephalic, Peripheral | Cephalic, Peripheral | ||
| Vessel, Abdominal, | Vessel, Abdominal, | ||
| Intraoperative Abdominal, | Intraoperative Abdominal, | ||
| Musculo-skeletal | Musculo-skeletal | ||
| Conventional, and | Conventional, and | ||
| Musculo-skeletal | Musculo-skeletal | ||
| Superficial applications. | Superficial applications. | ||
| The system also provides | The system also provides | ||
| Indications forUse | the ability to measureanatomical structures and | the ability to measureanatomical structures and | Identical |
| calculation packages thatprovide information to the | calculation packages thatprovide information to the | ||
| clinician that may be used | clinician that may be used | ||
| adjunctively with other | adjunctively with other | ||
| medical data obtained by a | medical data obtained by a | ||
| physician for clinical | physician for clinical | ||
| diagnosis purposes. | diagnosis purposes. | ||
| The typical examinations | The typical examinations | ||
| performed using the | performed using the | ||
| SC2000 Ultrasound | SC2000 Ultrasound | ||
| System are: | System are: | ||
| Cardiac ImagingApplications and Analysis | Cardiac ImagingApplications and Analysis | ||
| The system transmitsultrasound energy into | The system transmitsultrasound energy into | ||
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| adult, pediatric, neonatal,and fetal cardiac patientscreating 2D (B), 3D,MMode (M), ColorDoppler (CD), ColorPower Doppler (CPD),Pulsed Wave (PW)Doppler, and ContinuousWave Doppler (CWD) toobtain images and bloodflow velocity of the heart,cardiac valves, greatvessels, and surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem may be used toacquire patientelectrocardiogram forsynchronizing the diastolicand systolic capture ofultrasound images.The system also supportscatheters which areintended for intra-cardiacand intraluminalvisualization of cardiacand great vessel anatomyand physiology as well asvisualization of otherdevices in the heart of adultand pediatric patients. Thecatheter is intended forimaging guidance only, nottreatment delivery, duringcardiac interventionalpercutaneous procedures.The system has CardiacMeasurements andCalculation Packages thatprovide information that | adult, pediatric, neonatal,and fetal cardiac patientscreating 2D (B), 3D,MMode (M), ColorDoppler (CD), ColorPower Doppler (CPD),Pulsed Wave (PW)Doppler, and ContinuousWave Doppler (CWD) toobtain images and bloodflow velocity of the heart,cardiac valves, greatvessels, and surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem may be used toacquire patientelectrocardiogram forsynchronizing the diastolicand systolic capture ofultrasound images.The system also supportscatheters which areintended for intra-cardiacand intraluminalvisualization of cardiacand great vessel anatomyand physiology as well asvisualization of otherdevices in the heart of adultand pediatric patients. Thecatheter is intended forimaging guidance only, nottreatment delivery, duringcardiac interventionalpercutaneous procedures.The system has CardiacMeasurements andCalculation Packages thatprovide information that | ||
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| may be used adjunctivelywith other medical dataobtained by a physician forclinical diagnosispurposes.Vascular ImagingApplications and AnalysisThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), Pulsed WaveDoppler (PWD), andContinuous Wave Doppler(CWD) to obtain imagesand blood flow velocity ofthe carotid arteries orjuggler veins in the neck;superficial and deep veinsand arteries in the arms andlegs and abdomen; andsurrounding anatomicalstructures to evaluate thepresence or absence ofpathology. The systemmay be used to acquirepatient electrocardiogramfor synchronizing thediastolic and systoliccapture of ultrasoundimages. The system hasVascular Measurementsand Calculation Packagesthat provide informationthat may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | may be used adjunctivelywith other medical dataobtained by a physician forclinical diagnosispurposes.Vascular ImagingApplications and AnalysisThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), Pulsed WaveDoppler (PWD), andContinuous Wave Doppler(CWD) to obtain imagesand blood flow velocity ofthe carotid arteries orjuggler veins in the neck;superficial and deep veinsand arteries in the arms andlegs and abdomen; andsurrounding anatomicalstructures to evaluate thepresence or absence ofpathology. The systemmay be used to acquirepatient electrocardiogramfor synchronizing thediastolic and systoliccapture of ultrasoundimages. The system hasVascular Measurementsand Calculation Packagesthat provide informationthat may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | ||
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| Superficial ImagingApplicationsThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), Pulsed WaveDoppler (PWD), andContinuous Wave Doppler(CWD) to obtain imagesand blood flow velocity ofconventional or superficialmusculoskeletal structuresand surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem may be used toacquire patientelectrocardiogram forsynchronizing the diastolicand systolic capture ofultrasound images. | Superficial ImagingApplicationsThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), Pulsed WaveDoppler (PWD), andContinuous Wave Doppler(CWD) to obtain imagesand blood flow velocity ofconventional or superficialmusculoskeletal structuresand surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem may be used toacquire patientelectrocardiogram forsynchronizing the diastolicand systolic capture ofultrasound images. | ||
| Intraoperative ImagingApplicationsThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), and Pulsed WaveDoppler (PWD) to obtainimages and blood flowvelocity that provideguidance duringintraoperative procedures.Transcranial ImagingApplications | Intraoperative ImagingApplicationsThe system transmitsultrasound energy intovarious parts of the body ofadult patients creating 2D(B), Color Doppler (CD),Color Power Doppler(CPD), and Pulsed WaveDoppler (PWD) to obtainimages and blood flowvelocity that provideguidance duringintraoperative procedures.Transcranial ImagingApplications | ||
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| The system transmitsultrasound energy into thecranium of adult patientscreating 2D (B), ColorDoppler (CD), ColorPower Doppler (CPD),Pulsed Wave Doppler(PWD), and ContinuousWave Doppler (CWD) toobtain images and bloodflow velocity of the brainand surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem providesMeasurement Packagesthat provide informationthat may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | The system transmitsultrasound energy into thecranium of adult patientscreating 2D (B), ColorDoppler (CD), ColorPower Doppler (CPD),Pulsed Wave Doppler(PWD), and ContinuousWave Doppler (CWD) toobtain images and bloodflow velocity of the brainand surroundinganatomical structures toevaluate the presence orabsence of pathology. Thesystem providesMeasurement Packagesthat provide informationthat may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1 540 | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1 540 | ||
| Operatingprinciples | Identical | ||
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | ||
| Type ofPreviouslyclearedTransducers | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersTransesophagealTransducerUltrasound Catheter | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersTransesophagealTransducerUltrasound Catheter | Identical |
| Acoustic Outputs | Yes | Yes | Identical |
| Standard Feature | ACUSON SC2000Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON SC2000Diagnostic UltrasoundSystemK200585(Predicate Device) | Comparison |
| PreviouslyclearedImaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
ACUSON SC2000
{120}------------------------------------------------
{121}------------------------------------------------
Siemens Medical Solutions USA, Inc.
Ultrasound Division
{122}------------------------------------------------
{123}------------------------------------------------
{124}------------------------------------------------
{125}------------------------------------------------
| Standard Feature | ACUSON FreestyleDiagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON FreestyleDiagnostic UltrasoundSystemK200644(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The ACUSON FreestyleUltrasound System isintended for diagnosticimaging or fluid flowanalysis of the humanbody performed by anappropriately trainedhealthcare professional ina healthcare setting for thefollowing conditions:Abdominal, Pediatric,Small Organ, PeripheralVessel, Musculoskeletal(Conventional),Musculoskeletal(Superficial). | The ACUSON FreestyleUltrasound System isintended for diagnosticimaging or fluid flowanalysis of the humanbody performed by anappropriately trainedhealthcare professional ina healthcare setting for thefollowing conditions:Abdominal, Pediatric,Small Organ, PeripheralVessel, Musculoskeletal(Conventional),Musculoskeletal(Superficial). | Identical |
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operatingprinciples | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structures | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structures | Identical |
| Standard Feature | ACUSON FreestyleDiagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON FreestyleDiagnostic UltrasoundSystemK200644(Predicate Device) | Comparison |
| within the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, forexample, at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | within the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, forexample, at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | ||
| Type ofPreviouslycleared | Curved Array TransducerLinear Array Transducer | Curved Array TransducerLinear Array Transducer | Identical |
| Standard Feature | ACUSON FreestyleDiagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON FreestyleDiagnostic UltrasoundSystemK200644(Predicate Device) | Comparison |
| Transducers | |||
| Acoustic OutputsWithin Range? | Yes | Yes | Identical |
| Previouslycleared | Yes | Yes | Identical |
| Imaging Modes? | |||
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
ACUSON Freestyle
Siemens Medical Solutions USA, Inc. Ultrasound Division
{126}------------------------------------------------
{127}------------------------------------------------
| StandardFeature | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK172162(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The ultrasound imagingsystems are intended for thefollowing applications:Fetal, Abdominal,Intraoperative, Pediatric,Small Parts, Transcranial,OB/GYN (includingmonitoring of the ovarianfollicle development),Cardiac, Pelvic,Neonatal/Adult Cephalic,Vascular, Musculoskeletal,SuperficialMusculoskeletal, andPeripheral Vascularapplications.The system also providesthe ability to measureanatomical structures | The ultrasound imagingsystems are intended for thefollowing applications:Fetal, Abdominal,Intraoperative, Pediatric,Small Parts, Transcranial,OB/GYN (includingmonitoring of the ovarianfollicle development),Cardiac, Pelvic,Neonatal/Adult Cephalic,Vascular, Musculoskeletal,SuperficialMusculoskeletal, andPeripheral Vascularapplications.The system also providesthe ability to measureanatomical structures | Identical |
| Standard Feature | ACUSON S family (S1000/S2000/S3000) Diagnostic Ultrasound System K# Pending (Subject Device) | ACUSON S family (S1000/S2000/S3000) Diagnostic Ultrasound System K172162 (Predicate Device) | Comparison |
| {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. | {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. | ||
| The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify | The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify | ||
| StandardFeature | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK172162(Predicate Device) | Comparison |
| Subclinical VascularDisease and EvaluateCardiovascular DiseaseRisk: A ConsensusStatement from theAmerican Association ofEchocardiography; CarotidIntima-Media ThicknessTask Force, Endorsed bythe Society for VascularImaging". | Subclinical VascularDisease and EvaluateCardiovascular DiseaseRisk: A ConsensusStatement from theAmerican Association ofEchocardiography; CarotidIntima-Media ThicknessTask Force, Endorsed bythe Society for VascularImaging". | ||
| The ACUSON AcuNavUltrasound Catheter isintended for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology, as well asvisualization of otherdevices in the heart of adultand pediatric patients. | The ACUSON AcuNavUltrasound Catheter isintended for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology, as well asvisualization of otherdevices in the heart of adultand pediatric patients. | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operatingprinciples | Diagnostic ultrasound useshigh-frequency (above theaudible range) sound wavestoproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540 | Diagnostic ultrasound useshigh-frequency (above theaudible range) sound wavestoproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540 | Identical |
| StandardFeature | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK172162(Predicate Device) | Comparison |
| meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest from thetransducer surface requiremore time to return a signalthan structures closer to thetransducer surface. Thestrength and position ofeach signal indicates apoint of varying intensity(brightness). The distancesand intensities areprocessed and displayed ona screen to form a two-dimensional (2D)image. | meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest from thetransducer surface requiremore time to return a signalthan structures closer to thetransducer surface. Thestrength and position ofeach signal indicates apoint of varying intensity(brightness). The distancesand intensities areprocessed and displayed ona screen to form a two-dimensional (2D)image. | ||
| Type ofPreviouslyclearedTransducers | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersCurved Array Mechanical3D TransducerTransesophagealTransducerUltrasound Catheter | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersCurved Array Mechanical3D TransducerTransesophagealTransducerUltrasound Catheter | Identical |
| StandardFeature | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON S family(S1000/S2000/S3000)Diagnostic UltrasoundSystemK172162(Predicate Device) | Comparison |
| Within Range? | |||
| PreviouslyclearedImaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
ACUSON S-Family
{128}------------------------------------------------
{129}------------------------------------------------
{130}------------------------------------------------
{131}------------------------------------------------
| Standard Feature | ACUSON P200Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON P200Diagnostic UltrasoundSystemK191922(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The ACUSON P200ultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal,Pediatric, Small Parts,OB/GYN (useful forvisualization of theovaries, follicles, uterus,and other pelvicstructures), Adult,Pediatric and NeonatalCardiac, Pelvic, NeonatalCephalic, Vascular,Musculoskeletal,SuperficialMusculoskeletal, and | The ACUSON P200ultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal,Pediatric, Small Parts,OB/GYN (useful forvisualization of theovaries, follicles, uterus,and other pelvicstructures), Adult,Pediatric and NeonatalCardiac, Pelvic, NeonatalCephalic, Vascular,Musculoskeletal,SuperficialMusculoskeletal, and | Identical |
| Standard Feature | ACUSON P200Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON P200Diagnostic UltrasoundSystemK191922(Predicate Device) | Comparison |
| Peripheral Vascularapplications.The system also providesthe ability to measureanatomical structures;fetal, abdominal, pediatric,small organ, neonatalcephalic, cardiac (adult,pediatric and neonatal),trans-esophageal,transrectal, transvaginal,peripheral vessel,musculoskeletal(conventional),musculoskeletal(superficial) andcalculation packages thatprovide information to theclinician that may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | Peripheral Vascularapplications.The system also providesthe ability to measureanatomical structures;fetal, abdominal, pediatric,small organ, neonatalcephalic, cardiac (adult,pediatric and neonatal),trans-esophageal,transrectal, transvaginal,peripheral vessel,musculoskeletal(conventional),musculoskeletal(superficial) andcalculation packages thatprovide information to theclinician that may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operatingprinciples | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound waves | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound waves | Identical |
| Standard Feature | ACUSON P200Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON P200Diagnostic UltrasoundSystemK191922(Predicate Device) | Comparison |
| travel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, forexample, at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | travel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, forexample, at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest fromthe transducer surfacerequire more time to returna signal than structurescloser to the transducersurface. The strength andposition of each signalindicates a point of varyingintensity (brightness). Thedistances and intensitiesare processed anddisplayed on a screen toform a two-dimensional(2D)image. | ||
| Type ofPreviouslyclearedTransducers | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersTransesophagealTransducer | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersTransesophagealTransducer | Identical |
| Acoustic OutputsWithin Range? | Yes | Yes | Identical |
| Standard Feature | ACUSON P200Diagnostic UltrasoundSystemK# Pending(Subject Device) | ACUSON P200Diagnostic UltrasoundSystemK191922(Predicate Device) | Comparison |
| PreviouslyclearedImaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
ACUSON P200
{132}------------------------------------------------
{133}------------------------------------------------
{134}------------------------------------------------
ACUSON P500
| StandardFeature | ACUSON P500Ultrasound SystemK# Pending(Subject Device) | ACUSON P500Ultrasound SystemK163396(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The ACUSON P500ultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal(including liver), Pediatric,Small Parts, Transcranial,OB/GYN(useful forvisualization of ovaries,follicles, uterus and otherpelvic structures), Pelvic,Neonatal, Cardiac,IntraCardiac,Vascular(includingPeripheral Vessel),Musculoskeletal,SuperficialMusculoskeletal, andUrology applications.The system also providesthe ability to measureanatomical structures fetal,abdominal, small organ,transrectal, transvaginal,cardiovascular, peripheralvessel, musculoskeletal(conventional) and | The ACUSON P500ultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal(including liver), Pediatric,Small Parts, Transcranial,OB/GYN(useful forvisualization of ovaries,follicles, uterus and otherpelvic structures), Pelvic,Neonatal, Cardiac,IntraCardiac,Vascular(includingPeripheral Vessel),Musculoskeletal,SuperficialMusculoskeletal, andUrology applications.The system also providesthe ability to measureanatomical structures fetal,abdominal, small organ,transrectal, transvaginal,cardiovascular, peripheralvessel, musculoskeletal(conventional) and | Identical |
| Standard Feature | ACUSON P500Ultrasound SystemK# Pending(Subject Device) | ACUSON P500Ultrasound SystemK163396(Predicate Device) | Comparison |
| musculoskeletal(superficial) andcalculation packages thatprovide information to theclinician that may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | musculoskeletal(superficial) andcalculation packages thatprovide information to theclinician that may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes. | ||
| The Arterial HealthPackage (AHP) softwareprovides the physician withthe capability to measureIntima Media Thicknessand the option to referencenormative tables that havebeen validated andpublished in peer-reviewedstudies. The information isintended to provide thephysician with an easilyunderstood tool forcommunicating withpatients regarding state oftheir cardiovascularsystem. | The Arterial HealthPackage (AHP) softwareprovides the physician withthe capability to measureIntima Media Thicknessand the option to referencenormative tables that havebeen validated andpublished in peer-reviewedstudies. The information isintended to provide thephysician with an easilyunderstood tool forcommunicating withpatients regarding state oftheir cardiovascularsystem. | ||
| This feature should beutilized according to the"ASE ConsensusStatement; Use of CarotidUltrasound to IdentifySubclinical VascularDisease and EvaluateCardiovascular DiseaseRisk: A ConsensusStatement from theAmerican Society ofEchocardiography CarotidIntima-Media Thickness | This feature should beutilized according to the"ASE ConsensusStatement; Use of CarotidUltrasound to IdentifySubclinical VascularDisease and EvaluateCardiovascular DiseaseRisk: A ConsensusStatement from theAmerican Society ofEchocardiography CarotidIntima-Media Thickness | ||
| Standard Feature | ACUSON P500Ultrasound SystemK# Pending(Subject Device) | ACUSON P500Ultrasound SystemK163396(Predicate Device) | Comparison |
| the Society for VascularImaging." | the Society for VascularImaging." | ||
| The ACUSON AcunavUltrasound Catheter isintended for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology, as well asvisualization of otherdevices in the heart of adultand pediatric patients. | The ACUSON AcunavUltrasound Catheter isintended for intra-cardiacand intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology, as well asvisualization of otherdevices in the heart of adultand pediatric patients. | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body. | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body. | ||
| Operatingprinciples | Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information aboutthe | Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information aboutthe | Identical |
| StandardFeature | ACUSON P500Ultrasound SystemK# Pending(Subject Device) | ACUSON P500Ultrasound SystemK163396(Predicate Device) | Comparison |
| acoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest from thetransducer surface requiremore time to return a signalthan structures closer to thetransducer surface. Thestrength and position ofeach signal indicates apoint of varying intensity(brightness). The distancesandintensities areprocessed and displayed ona screen to form a two-dimensional (2D)image. | acoustic properties of thetissue. The time to receivethe echo in microsecondsindicates adistance into the body.Structures furthest from thetransducer surface requiremore time to return a signalthan structures closer to thetransducer surface. Thestrength and position ofeach signal indicates apoint of varying intensity(brightness). The distancesandintensities areprocessed and displayed ona screen to form a two-dimensional (2D)image. | ||
| Type ofPreviouslyclearedTransducers | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersUltrasound Catheter | Curved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersUltrasound Catheter | Identical |
| Acoustic OutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyclearedImaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
{135}------------------------------------------------
{136}------------------------------------------------
{137}------------------------------------------------
ACUSON NX3/NX3 Elite
| StandardFeature | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK# Pending(Subject Device) | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK192835(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | ACUSON NX3 | ACUSON NX3 | Identical |
| StandardFeature | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK# Pending(Subject Device) | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK192835(Predicate Device) | Comparison |
| The ACUSON NX3ultrasound imaging systemis intended for thefollowing applications: | The ACUSON NX3ultrasound imaging systemis intended for thefollowing applications:Fetal Abdominal(including liver), Pediatric,Small Parts (Small Organ),Neonatal Cephalic, AdultCephalic, Transcranial,OB/GYN, Pelvic,Neonatal, Cardiac,Vascular (includingPeripheral Vessel),Musculoskeletal,SuperficialMusculoskeletal andUrology applications. | ||
| The systems also providefor the measurement ofanatomical structures andfor analysis packages thatprovide information that isused for clinical diagnosispurposes. | The systems also providefor the measurement ofanatomical structures andfor analysis packages thatprovide information that isused for clinical diagnosispurposes. | ||
| ACUSON NX3 EliteThe ACUSON NX3 Eliteultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal(including liver, intra-operative), Pediatric, SmallParts (Small Organincluding intra-operative),Neonatal Cephalic, AdultCephalic, Transcranial,OB/GYN, Pelvic,Neonatal, Cardiac,Vascular (including | ACUSON NX3 EliteThe ACUSON NX3 Eliteultrasound imaging systemis intended for thefollowing applications:Fetal, Abdominal(including liver, intra-operative), Pediatric, SmallParts (Small Organincluding intra-operative),Neonatal Cephalic, AdultCephalic, Transcranial,OB/GYN, Pelvic,Neonatal, Cardiac,Vascular (including | ||
| StandardFeature | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK# Pending(Subject Device) | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK192835(Predicate Device) | Comparison |
| Peripheral Vessel, intra-operative),Musculoskeletal,SuperficialMusculoskeletal andUrology applications. | Peripheral Vessel, intra-operative),Musculoskeletal,SuperficialMusculoskeletal andUrology applications. | ||
| The systems also providefor the measurement ofanatomical structures andfor analysis packages thatprovide information that isused for clinical diagnosispurposes. | The systems also providefor the measurement ofanatomical structures andfor analysis packages thatprovide information that isused for clinical diagnosispurposes. | ||
| The Arterial HealthPackage (AHP) softwareprovides the physician withthe capability to measureIntima Media Thicknessand the option to referencenormative tables that havebeen validated andpublished in peer-reviewedstudies. The information isintended to provide thephysician with an easilyunderstood tool forcommunicating withpatients regarding state oftheir cardiovascularsystem. | The Arterial HealthPackage (AHP) softwareprovides the physician withthe capability to measureIntima Media Thicknessand the option to referencenormative tables that havebeen validated andpublished in peer-reviewedstudies. The information isintended to provide thephysician with an easilyunderstood tool forcommunicating withpatients regarding state oftheir cardiovascularsystem. | ||
| Note: This feature shouldbe utilized according to the"ASE ConsensusStatement; Use of CarotidUltrasound to IdentifySubclinical VascularDisease and EvaluateCardiovascular Disease | Note: This feature shouldbe utilized according to the"ASE ConsensusStatement; Use of CarotidUltrasound to IdentifySubclinical VascularDisease and EvaluateCardiovascular Disease | ||
| StandardFeature | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK# Pending(Subject Device) | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK192835(Predicate Device) | Comparison |
| Risk: A ConsensusStatement from theAmerican Society ofEchocardiography; CarotidIntima-Media ThicknessTask Force, Endorsed bythe Society for VascularMedicine.". | Risk: A ConsensusStatement from theAmerican Society ofEchocardiography; CarotidIntima-Media ThicknessTask Force, Endorsed bythe Society for VascularMedicine.". | ||
| Reusable? | Yes | Yes | Identical |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical |
| ScientificTechnology | Ultrasound Imaging | Ultrasound Imaging | Identical |
| Operatingprinciples | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates a | Diagnostic ultrasound useshigh-frequency (above theaudible range) soundwaves toproduce an image ofanatomical structureswithin the body. Electricalpulses vibrateceramics within atransducer to transmit thesound waves into the body.Sound wavestravel through body tissueat approximately 1,540meters per second andreflect back asechoes to the transducer ateach point of change intissue density, for example,at theborder of two organs in thebody. These return signalsprovide information abouttheacoustic properties of thetissue. The time to receivethe echo in microsecondsindicates a | Identical |
| Standard Feature | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK# Pending(Subject Device) | ACUSON NX3/NX3Elite DiagnosticUltrasound SystemK192835(Predicate Device) | Comparison |
| distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image. | distance into the body. Structures furthest from the transducer surface require more time to return a signal than structures closer to the transducer surface. The strength and position of each signal indicates a point of varying intensity (brightness). The distances and intensities are processed and displayed on a screen to form a two-dimensional (2D) image. | ||
| Type ofPreviouslyclearedTransducers | NX3Curved Array TransducerLinear Array TransducerPhased Array TransducerCurved Array Mechanical3D TransducerNX3 EliteCurved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersCurved Array Mechanical3D TransducerTransesophagealTransducer | NX3Curved Array TransducerLinear Array TransducerPhased Array TransducerCurved Array Mechanical3D TransducerNX3 EliteCurved Array TransducerLinear Array TransducerPhased Array TransducerContinuous WaveTransducersCurved Array Mechanical3D TransducerTransesophagealTransducer | Identical |
| Acoustic OutputsWithin Range? | Yes | Yes | Identical |
| PreviouslyclearedImaging Modes? | Yes | Yes | Identical |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
Siemens Medical Solutions USA, Inc. Ultrasound Division
{138}------------------------------------------------
{139}------------------------------------------------
{140}------------------------------------------------
{141}------------------------------------------------
{142}------------------------------------------------
Substantial Equivalence Conclusion:
From the information provided in Table 2 above: it is understood that the subject device does not introduce any new fundamental technology or modify the indications of use; therefore, the listed ACUSON Diagnostic Ultrasound systems as listed in Table 2 are considered substantially equivalent to their individual predicate devices including the expanded labeling.
Part 7. A brief discussion of nonclinical testing submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The Customer Requirement Specifications (CRS) for each listed ACUSON Diagnostic Ultrasound device was verified and validated according to the design control requirements of 21 CFR 820.30 during the original project development of the predicate version of each device and remain unchanged from their currently cleared configuration. Each predicate version of the listed device has been subjected to extensive safety and requirements verification testing before release to ensure the device meets all its specifications including conformance to the following standards:
- IEC 62304:2006/A1:2016 Medical Device Software Software Life Cycle Processes ●
- IEC 62366-1:2015, Application of usability engineering to medical devices. .
- . NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM set).
The testing results for each listed ACUSON Diagnostic Ultrasound System to support the claim of conformity are available upon request. There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission.
For the expanded Labeling for each ACUSON Diagnostic Ultrasound Device as listed above, the use of currently cleared customizable PreSets will be supported by availability of the Educational materials and current literature currently posted on the Siemens Healthineers website and included in this submission under Labeling.
Software Verification and Validation
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission.
{143}------------------------------------------------
The expanded Labeling for customer use of educational and training materials specifically for Lung Ultrasound imaging does not impact the software for any listed device.
Cybersecurity considerations related to the ACUSON Diagnostic Ultrasound systems device software has been address within each product. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
A risk analysis, in compliance with ISO 14971:2007, for each of the ACUSON Diagnostic Ultrasound systems device during their development of the predicate devices was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirm that all software specifications have been implemented on the respective predicate devices and met the defined acceptance criteria. The predicate devices remain unchanged from their currently cleared software version, configuration and accessories.
Note: Risk analysis was performed by the Risk management team by review of clinical literature.
Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
The ACUSON Diagnostic Ultrasound systems device are all FDA Class II devices and uses the same technology and operating principles as their respective predicate devices, therefore clinical studies were not required to support substantial equivalence, The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature.
Part 9. Safety and Effectiveness Information
The currently cleared Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of each device listed. Risk management was implemented throughout the development process for each ACUSON Diagnostic Ultrasound system to control potential hazards. Siemens believes that the expanded Labeling is safe and effective for the use of instructions for Lunq ultrasound imaging (LUS) and does not introduce new safety and effectiveness concerns.
Part 10. Conclusion as to Substantial Equivalence Summary
Based on the information provided here in the summary and from the device comparison in Table 2; ACUSON Diagnostic Ultrasound systems have the same indications for use as the primary predicate devices. The device Labeling has been expanded to include information regarding the use of Ultrasound Imaging of the Lung imaging by the use of adequate descriptions necessary for training on scanning
Siemens Medical Solutions USA, Inc. Ultrasound Division
{144}------------------------------------------------
techniques for Lung imaging, description for Users to create Lung Preset settings by using the Preset Customization tools currently available on all cleared ACUSON devices indicated in this submission and referencing clinical information distributed to the clinicians various peer reviewed Journal articles.
There are no new features or software changes from the primary predicate devices and no new issues of safety or effectiveness are raised.
Siemens Medical Solutions USA, Inc, Ultrasound Business Unit considers the all of the ACUSON Diagnostic Ultrasound systems with expanded Labeling to be substantially equivalent with respect to safety and effectiveness to the previously cleared predicate devices for the U.S. market.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.