(20 days)
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, 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 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.
The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are 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, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
This document is a 510(k) premarket notification from Siemens Medical Solutions USA, Inc. for their ACUSON NX3 Diagnostic Ultrasound System and ACUSON NX3 Elite Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices (K173957).
Analysis of Acceptance Criteria and Study Design:
This document describes a submission for a change to Indications for Use for an existing device, rather than a clinical study establishing performance of a new device or software. Therefore, the typical structure of acceptance criteria and a study design proving a device meets these criteria (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) is not present in this document.
Instead, the document asserts substantial equivalence based on:
- Technological Characteristics: The devices are fundamentally the same as their predicates, with the same core function (ultrasound imaging), modes of operation, and most features.
- Expanded Indications for Use: The main purpose of this submission is to expand the stated Indications for Use for the existing ACUSON NX3 and ACUSON NX3 Elite systems, and specifically to update the Indications for Use for the VF13-5sp transducer. These expansions primarily involve applications (e.g., "cardiac (including transesophageal)" and "small parts to the intra-operative clinical application") that were already cleared on the predicate devices or with other transducers.
Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" as typically applied to performance claims (e.g., for an AI/ML algorithm) needs to be reinterpreted in the context of a 510(k) for an updated Indications for Use of an existing ultrasound system.
Therefore, the "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for an expanded intended use, which primarily relies on technological similarity and safety/performance data already established for the predicate device.
Here's an attempt to answer your questions based on the provided document, noting that many items will be answered as "Not Applicable" or "Not Provided" because this is a 510(k) for an existing device with expanded indications, not a performance study for a novel AI/ML algorithm:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) for expanding indications of an existing ultrasound system, not a new AI/ML device with specific performance claims (e.g., sensitivity, specificity), a direct "acceptance criteria" table with performance metrics isn't explicitly defined in the document. The acceptance criterion is "substantial equivalence" to the predicate, demonstrated by listing comparable technological characteristics and intended uses.
| Acceptance Criterion (Implicit for 510(k) of Expanded Indications) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Safety and Effectiveness (comparable to predicate) | Confirmed through compliance with applicable medical device safety standards (AIUM/NEMA UD-3:2004, AIUM/NEMA UD-2:2004 (R2009), IEC 62359:2010, AAMI ES60601-1:2005, IEC 60601-1:2005, IEC 60601-1-2 Edition 4.0, IEC 60601-2-18: Edition 3.0, IEC 60601-2-37 Edition 2.1, ISO 10993-1). |
| Technological Characteristics (substantially equivalent to predicate) | All listed features (Indications for Use, Center Frequencies, Modes, Features like 3D/4D Imaging, Stress Echo, DICOM, etc.) are identical between the submission devices and their respective predicate devices (ACUSON NX3 and ACUSON NX3 Elite K173957), as indicated by the "√" in the comparison table. Some indications are new to specific device/transducer combinations but were previously cleared on other parts of the predicate system. |
| Intended Use (consistent with predicate and traditional clinical practice) | Expanded indications ("cardiac (including transesophageal)" and "small parts to intra-operative clinical application" for VF13-5sp transducer) were already cleared either on the predicate device or with other transducers in the predicate system. The information for Arterial Health Package (AHP) is referenced to peer-reviewed studies and professional consensus statements. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission is for expanded indications of an existing ultrasound system, not a clinical study with a test set for performance evaluation of a new algorithm. The manufacturer states that "clinical data is not required" because the devices use the "same technology and principles as existing devices."
- Data Provenance: Not applicable for a new clinical study. The existing data supporting the predicate device's clearance would have been used. The document does not specify the provenance of data for the original predicate clearance (K173957), but it did not rely on
clinical data. The AHP feature references peer-reviewed studies, but these are not for the device's performance, but for the underlying normative tables.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No new clinical test set requiring expert-established ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical test set requiring adjudication was performed for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device; it is a diagnostic ultrasound system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a diagnostic imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a new clinical study. The existing predicate device was cleared without new clinical data. The AHP feature bases its normative tables on "peer-reviewed studies" and "ASE Consensus Statement."
8. The sample size for the training set:
- Not applicable. This is hardware (ultrasound system) with software, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is hardware (ultrasound system) with software, not a machine learning model.
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Image /page/0/Picture/0 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. % Mr. Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
October 22, 2019
Re: K192835
Trade/Device Name: ACUSON NX3 Diagnostic Ultrasound System / ACUSON 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 Dated: October 1, 2019 Received: October 2, 2019
Dear Mr. Bom:
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 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
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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
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Indications for Use
510(k) Number (if known)
K192835
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, 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 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.
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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( 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) | 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)
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
For example: abdominal, vascular Note 2 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 1 of 19
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510(k) Number (if known):
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(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) | |||||||||
| Fetal | LaparoscopicPediatric | 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
Note 3 For example: abdominal, vascular
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
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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(Tracks 1& 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 | P | P | P | P | P | P | ||
| 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) | |||||||||
| 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 3 of 19
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510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with:
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(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalAbdominal | 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) | ||||||||||
| 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 4 of 19
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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( Track 1Only) | 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 | |||||||||
| 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.) | 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 | 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 5 of 19
{9}------------------------------------------------
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( Track 1Only) | Specific(Tracks1& 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | Other(Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | 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) | |||||||||
| 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 6 of 19
{10}------------------------------------------------
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( 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 | ||||||||||
| Intra-operative(Note 2) | ||||||||||
| Intra-operative(Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| FetalImaging& Other | Pediatric | |||||||||
| SmallOrgan(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) |
- non-incidentally + previously cleared?) (.)
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 7 of 19
{11}------------------------------------------------
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( Track 1Only) | 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) |
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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 8 of 19
{12}------------------------------------------------
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 | 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 | |||||||||
| FetalImaging& Other | 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-vascularOther | |||||||||
| (Specify) | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac | 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) |
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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 9 of 19
{13}------------------------------------------------
510(k) Number (if known):
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:
Device Name:
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 | 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.) | ||||||||||
| 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) |
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
{14}------------------------------------------------
510(k) Number (if known):
VF16-5 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:
| 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 | |||||||||||
| 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 | ||||||||||
| 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 11 of 19
Indications for Use Forms
{15}------------------------------------------------
510(k) Number (if known):
VF13-5sp 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: Mode c Clinical Applicatio of O ati
| Other(Track1Only) | Specific(Tracks1& 3) | Mode of Operation | Other(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | ||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative(Note 2) | P | P | P | P | P | P | |||
| 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(Note 1) | 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, 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
{16}------------------------------------------------
510(k) Number (if known):
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other(Track1Only) | Specific(Tracks1 & 3) | B | M | PWD | CWD | ColorDoppler | PowerDoppler | Combined(Note 3) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative(Note 2) | |||||||||
| 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 | |||||||||
| Intra-vascular(Cardiac) | |||||||||
| Trans-esophageal(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
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 13 of 19
{17}------------------------------------------------
510(k) Number (if known):
Intended Use:
C8-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| 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 | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | P | P | |
| Imaging& Other | SmallOrgan(Note 1) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | P | 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 | P | |
| 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 14 of 19
{18}------------------------------------------------
510(k) Number (if known):
P8-4 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( Track 1Only) | 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) | ||||||||||
| Neonatal Cephalic | 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 | |||
| 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
{19}------------------------------------------------
510(k) Number (if known):
11L4 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(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 | |||||||||
| 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 | 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 16 of 19
{20}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
10MC3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System /
ACUSON NX3™ Diagnostic Ultrasound System
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 | |||||||||
| Intra-operative(Note 2) | |||||||||
| Intra-operative(Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging& Other | 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) | |||||||||
| 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
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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(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 | |||||||||
| 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
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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( 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 | |||||||||
| 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) | P | P | P | P | P | P | P | ||
| 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
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| 510(k) Summary | K192835 | |||
|---|---|---|---|---|
| Date: | August 25, 2019 | |||
| 1. Sponsor: | Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043 | |||
| Contact Person: | Hyunjung LeeTel: (425) 281-5061 | |||
| 2. Device Name: | ACUSON NX3 Diagnostic Ultrasound SystemACUSON NX3 Elite Diagnostic Ultrasound System | |||
| Common Name: | Diagnostic Ultrasound System with Accessories | |||
| Classification: | Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology | |||
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | ||
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | ||
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | ||
| ManufacturingFacility: | Siemens Healthineers Ltd.2nd -3rd floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do, Republic of Korea |
3. Legally Marketed Predicate Devices
The ACUSON NX3 Elite Diagnostic Ultrasound System and ACUSON NX3 Diagnostic Ultrasound System are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current product, ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K173957).
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4. Device Description
The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are 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, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
5. Intended Use/ Indications for use
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, 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 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.".
6. Summary of Technological Characteristics
The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products, the ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K173957). All systems transmit ultrasonic energy into patients, and then perform post processing of received echoes to generate onscreen display of anatomic
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structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
The submission devices are substantially equivalent to the predicate with regard to both intended use and technological characteristics.
| Feature / Characteristic | PredicateDeviceACUSONNX3TM(K173957) | PredicateDeviceACUSON NX3EliteTM(K173957) | SubmissionDeviceACUSON NX3 | SubmissionDeviceACUSON NX3Elite |
|---|---|---|---|---|
| Indications for Use: | ||||
| ■ Fetal Echo | √ | √ | √ | √ |
| ■ Abdominal | √ | √ | √ | √ |
| ■ Intra-operative | - | √ | - | √ |
| ■ Neonatal Cephalic | - | √ | - | √ |
| ■ Small Organ(parts) | √ | √ | √ | √ |
| ■ Pediatric | √ | √ | √ | √ |
| ■ Adult Cephalic (Trans-cranial) | √ | √ | √ | √ |
| ■ Cardiac (Adult) | √ | √ | √ | √ |
| ■ Cardiac (Pediatric) | √ | √ | √ | √ |
| ■ Intracardiac | - | - | - | - |
| ■ Trans-esophageal | - | √ | - | √ |
| ■ Trans-rectal | √ | √ | √ | √ |
| ■ Trans-vaginal | √ | √ | √ | √ |
| ■ Peripheral vessel | √ | √ | √ | √ |
| ■ Musculo-skeletal(conventional) | √ | √ | √ | √ |
| ■ Musculo-skeletal(superficial) | √ | √ | √ | √ |
| Center FrequenciesSupported: | ||||
| ■ 2.0 MHz | √ | √ | √ | √ |
| ■ 2.5 MHz | √ | √ | √ | √ |
| ■ 3.0 MHz | √ | √ | √ | √ |
| ■ 3.5 MHz | √ | √ | √ | √ |
| ■ 4.0 MHz | √ | √ | √ | √ |
| ■ 5.0 MHz | √ | √ | √ | √ |
| ■ 5.5 MHz | √ | √ | √ | √ |
| ■ 6.0 MHz | √ | √ | √ | √ |
| ■ 6.5 MHz | √ | √ | √ | √ |
| ■ 7.5 MHz | √ | √ | √ | √ |
| ■ 8.0 MHz | √ | √ | √ | √ |
| ■ 9.0 MHz | √ | √ | √ | √ |
| ■ 10.0 MHz | √ | √ | √ | √ |
| ■ 11.0 MHz | √ | √ | √ | √ |
| ■ 12.0 MHz | - | √ | - | √ |
| ■ 13.0 MHz | - | √ | - | √ |
| Modes: | ||||
| ■ B | √ | √ | √ | √ |
| ■ M | √ | √ | √ | √ |
| Feature / Characteristic | PredicateDeviceACUSONNX3TM(K173957) | PredicateDeviceACUSON NX3EliteTM(K173957) | SubmissionDeviceACUSON NX3 | SubmissionDeviceACUSON NX3Elite |
| PWD (Pulsed WaveDoppler) | √ | √ | √ | √ |
| CWD (Continuous WaveDoppler) | - | √ | - | √ |
| SCW (Steerable CW) | √ | √ | √ | √ |
| CD (Color Doppler) | √ | √ | √ | √ |
| Amplitude Doppler(Power Doppler) | √ | √ | √ | √ |
| Directional Power Doppler | √ | √ | √ | √ |
| Combined (BM, BC, BCM,BCD) | √ | √ | √ | √ |
| THI (Tissue HarmonicImaging) | √ | √ | √ | √ |
| AMM (Anatomical M-mode) | √ | √ | √ | √ |
| Doppler Tissue Image(Color, PW) | √ | √ | √ | √ |
| M-THI | √ | √ | √ | √ |
| Features: | ||||
| Multi-View SpatialCompounding (SieClear) | √ | √ | √ | √ |
| Advanced SieClear | √ | √ | √ | √ |
| DTCE (Dynamic TissueContrast Enhancement) | √ | √ | √ | √ |
| Tissue GrayscaleOptimization (TGO) | √ | √ | √ | √ |
| Dual-Beam Processing | √ | √ | √ | √ |
| Quad-Beam Processing | √ | √ | √ | √ |
| Clip Capture | √ | √ | √ | √ |
| 3D Imaging (3-Scape 3D) | √ | √ | √ | √ |
| 3D Measurements | √ | √ | √ | √ |
| 4D Basic Imaging(fourSight 4D) | √ | √ | √ | √ |
| Panoramic 2D Imaging(SieScape) | √ | √ | √ | √ |
| Syngo Auto OB | √ | √ | √ | √ |
| Syngo Auto Follicle | √ | √ | √ | √ |
| Cardiac Imagingphysiological signaldisplaymultiplane TEEfourSight TEE Imaging | - | √ | - | √ |
| Stress Echo | √ | √ | √ | √ |
| Vascular Enhancement(Clarify VE) | √ | √ | √ | √ |
| Syngo VVI (VelocityVector Image) | √ | √ | √ | √ |
| Syngo Auto Left Heart(Auto LH) | - | √ | - | √ |
| Feature / Characteristic | PredicateDeviceACUSONNX3TM(K173957) | PredicateDeviceACUSON NX3EliteTM(K173957) | SubmissionDeviceACUSON NX3 | SubmissionDeviceACUSON NX3Elite |
| ■ Syngo AHP | - | √ | - | √ |
| ■ Contrast Agent Image | - | √ | - | √ |
| ■ Advanced fourSight 4D | - | √ | - | √ |
| ■ DIMAQ | √ | √ | √ | √ |
| ■ Multiple FrequencyImaging(MultiHertz) | √ | √ | √ | √ |
| ■ syngo Mitral ValveAssessments (MVA) | - | √ | - | √ |
| ■ Digital Architecture | √ | √ | √ | √ |
| ■ HD Zoom | √ | √ | √ | √ |
| ■ Fully integrated DICOM | √ | √ | √ | √ |
| ■ Monitor: FPD | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) |
| ■ Wireless | √ | √ | √ | √ |
| ■ eSie Touch | - | √ | - | √ |
| # Channels | 64 | 64 | 64 | 64 |
| Output Display Standard(Track 3) | √ | √ | √ | √ |
| Patient Contact Materials | Tested to ISO10993-1 | Tested to ISO10993-1 | Tested to ISO10993-1 | Tested to ISO10993-1 |
| UL60601-1 Certified | √ | √ | √ | √ |
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Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX3 Elite™ & ACUSON NX3TM Diagnostic Ultrasound System 510(k) Submission
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ACUSON NX3 Elite™ & ACUSON NX3™ Diagnostic Ultrasound System 510(k) Submission
7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:
- AIUM/NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2:2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- 트 IEC 62359:2010, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / This document and its separate amendments continue to be valid together with the consolidated version.
- I Safety and EMC Requirements for Medical Equipment
- O AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for O basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version
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- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: O Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: Particular O requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- I ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.
9. Summary
This submission expands the Indications for Use from "cardiac (including transesophageal)". The submission also adds "small parts" to the intra-operative clinical application of the VF13-5sp transducer. The cardiac (including transesophageal) clinical application was cleared in the V5Ms transducer with the predicate device. The small parts clinical application was also already cleared in the predicate device but not included in the Indications for Use of the VF13-5sp transducer. With this submission, Siemens intends to merely update the Indications for Use of the ACUSON NX3/ELITE and the Indications for Use of the VF13-5sp transducer, both of which were already cleared through the predicate. Other than the updates described in this paragraph, there has been no system or software modification to the subject device. The predicate device and subject device are the same.
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485 quality system standards. The products are designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical that the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are verified and validated according to the company's design control process.
§ 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.