(12 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML, such as automated image analysis beyond standard measurements or advanced pattern recognition.
No
The device description states its function is to "acquire primary or secondary harmonic ultrasound echo data and display it," and its intended use is for "clinical diagnosis purposes," indicating it is a diagnostic imaging system, not a therapeutic one.
Yes
The device description explicitly states, "The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system."
No
The device description explicitly states it is a "Diagnostic Ultrasound System" and describes hardware components like transducers (implied by the mention of acquiring echo data) and a Flat Panel Display, indicating it is a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SC2000 ultrasound imaging system uses ultrasound waves to create images of internal anatomical structures. It does not analyze samples taken from the body.
- Intended Use: The intended use describes imaging applications and measurements of anatomical structures. This is consistent with diagnostic imaging, not in vitro testing.
The device is a diagnostic imaging system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, 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
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OBJ
Device Description
The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000 Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Neo-natal and Fetal Cardiac, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Adult Cephalic.
Indicated Patient Age Range
adult, pediatric, neonatal, and fetal
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Since the SC2000 uses the same technology and principles as existing devices, clinical data is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary Prepared October 18, 2012
DEC 0 5 2012
-
- Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
- Contact Person: Patrick J. Lynch (650) 694-5658 Telephone: (650) 694-5580 Fax:
- Acuson SC2000™ Diagnostic Ultrasound System 2. Device Name:
- Common Name: Diagnostic Ultrasound System
Classification:
Requlatory Class: ll Review Category: Tier II Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code OBJ |
3. Legally Marketed Predicate Devices
The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K113179, the Acuson S2000 (K111674) and the Acuson X300 (K121699).
4. Device Description:
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
The SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP)
1
5. Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac. Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information 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 creating 2D (B), 3D, M-Mode (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 heart, cardiac valves, creat 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 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 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 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 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 neurological 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.
2
6. Summary of Technological Characteristics -- New Device Compared to Predicate
The submission device is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365, K102017 and K113179 with regard to both intended use and technological characteristics.
| Description | Acuson
SC2000TM
K113179 | Acuson
S2000
K111674 | Acuson
X300
K121699 | Acuson
SC2000TM
This
submission |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------|---------------------------|------------------------------------------|
| System: | | | | |
| Hardware Safety - EN60601-1 Certified | X | | | X |
| Software Safety - EN60601-4 Certified | X | | | X |
| Acoustic Thermal Safety - EN60601-2-37 Certified | X | | | X |
| Transducers: | | | | |
| See Table in Section 4.4.1.4 - All previously cleared | X | | | X |
| Biocompatibility - Same transducers no new materials | X | | | X |
| V7M Transducer | | X | X | X |
| 10V4 Transducer | | X | X | X |
| AcuNav 8F/10F | X | | | X |
| AcuNav V | X | | | X |
| Soundstar 10F | X | | | X |
| Biocompatibility - Same transducers no new materials | X | | | X |
| Accessories: | | | | |
| Respirometer | X | | | X |
| Biocompatibility | X | | | X |
| AcuNav Joystick | X | | | X |
| Imaging: | | | | |
| SpaceTimeTM resolution control | X | | | X |
| NativeTM Tissue Harmonic Imaging | X | | | X |
| MultiHertz multiple frequency imaging | X | | | X |
| RESTM enhanced resolution imaging format | X | | | X |
| Output display standard compliance | X | | | X |
| Native TEQTM dynamic ultrasound technology | X | | | X |
| TEQTM ultrasound technology | X | | | X |
| TEQTM technology for Spectral PW and CW Doppler | X | | | X |
| Dual screen and live dual imaging | X | | | X |
| Acoustic clip capture | X | | | X |
| eSie Measure Workflow Acceleration | X | | | X |
| Preset functionality with preset ordering and grouping
capabilities and linking to MultiHertzTM multiple frequency
imaging | X | | | X |
| Integrated Stress echo capability | X | | | X |
| Cardiac imaging and quantification package | | | X | |
| DTI™ Doppler tissue imaging includes the following color
Doppler capabilities: | X | | X | |
| DTI Velocity (DTV) | X | | X | |
| Color Doppler Harmonic capability in DTI | X | | X | |
| High Frame Rate Tissue Doppler (HTD) Capability | X | | X | |
| DTI Energy (DTE) | X | | X | |
| Color Doppler Velocity (CDV) | X | | X | |
| Color Harmonic imaging | X | | X | |
| DTI Pulsed Wave (DTI PW) capability | X | | X | |
| Color Doppler M-Mode for: | X | | X | |
| CDV | X | | X | |
| DTV | X | | X | |
| DTE | X | | X | |
| Contrast Imaging | | | | |
| Cadence™ contrast pulse sequencing technology (CPS) | X | | X | |
| PrecisonBurst programmable triggering for contrast agent
destruction | X | | X | |
| TEQ and NTEQ ultrasound technology for Cadence™ CPS | X | | X | |
| Cardiac Calculations: | | | | |
| Cardiac calculations package | X | | X | |
| Slope Line calculations | X | | X | |
| Generic Calculations/Ratio function | X | | X | |
| Vascular imaging package | | | | |
| B-mode, M-mode, NTHI, CPS, PW Doppler, Triplex imaging
and High Resolution Color Flow (HRCF) | X | | X | |
| Cadence™ CPS Capture | X | | X | |
| Advanced SieClear™ spatial compounding with Dynamic TCE
TM (tissue contrast enhancement) technology | X | | X | |
| Advanced Vascular Analysis report package | X | | X | |
| Clarify™ Vascular Enhancement Technology | X | | X | |
| Linear and Vector imaging formats | X | | X | |
| Auto Doppler option | X | | X | |
| Time averaged velocity (TAV) calculation | X | | X | |
| Vascular Calculation package | X | | X | |
| Transcranial imaging | X | | X | |
| Application packages: | | | | |
| syngo® Mitral Valve Assessment | X | | X | |
| syngo® auto Ejection Fraction technology | X | | X | |
| D1ART with syngo® fourSight™ TEE view | X | | X | |
| syngo® Quantitative Synch Tools™ technology (QST) | X | | X | |
| syngo® Velocity Vector Imaging™ technology (VVI) rotation | X | | X | |
| syngo® ACQ auto-tracking contrast quantification | x | | | x |
| Connectivity: | | | | |
| Wireless Network Connectivity | | | x | x |
| DICOM Print Service | x | | | x |
| DICOM Media Storage Service | x | | | x |
| DICOM Structured Reporting | x | | | x |
3
4
7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The SC2000™is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the SC2000 included various safety and performance testing designed to ensure the device meets all of its specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards including:
The Acuson SC2000™ has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- 이 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- . Safety and EMC Requirements for Medical Equipment
- · IEC 60601-1
- IEC 60601-1-1 .
- . IEC 60601-1-2
- . IEC 1157 Declaration of Acoustic Power
- . ISO 10993-1 Biocompatibility
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalent
Since the SC2000 uses the same technology and principles as existing devices, clinical data is not required.
9. Summary
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 21CFR820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the SC2000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 5, 2012
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official · Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K123622
Trade/Device Name: SC2000TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and OBJ Dated: November 21, 2012 Received: November 23, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the SC2000™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 9L4 | AcuNav 8F and 10F Ultrasound Catheter |
|---|---|
| V5M TEE | ACUSON AcuNav™ V 10F Ultrasound |
| 4V1c | Catheter |
| 8V3c | SoundStar 10F Ultrasound Catheter |
| AUX CW2 | V7M TEE |
| 4Z1c | 10V4 |
| ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
6
it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours,
Michael D. O'Hare
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
7
510(k) Number (if known):
Device Name:
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, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, 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, M-Mode (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 heart, 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 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 system transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (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 heart, 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 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 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.
8
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 neurological 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)
Page 1 of
Muhal D. O'kin
(Division Sign Off)
(Division Sign Off
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) K123622
9
510(k) Number (if known):
Device Name:
SC2000 Diagnostic Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P* | P | | P |
| Abdominal | P | P | P | P | P | P | P | | P* | P | | |
| Intraoperative
Abdominal | P | P | P | P | P | P | P | | P* | P | | |
| Intraoperative
Neurological | P | P | P | P | | P | P | | P* | P | | |
| Pediatric | P | P | P | P | P | P | P | | P* | P | P | P |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P* | P | | |
| Cardiac | P | P | P | P | P | P | P | | P* | P | P | P |
| Trans-esophageal | P | P | P | P | P | P | | | P* | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | | P |
| Peripheral Vessel | P | P | P | P | P | P | P | P | P* | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | | P | P | P | P* | P | | |
| Musculo-skeletal
Superficial | P | P | P | P | | P | P | P | P* | P | | |
| Other (Neonatal
Cardiac) | P | P | P | P | P | P | P | | P* | P | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | | P |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
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Division of Radiological Health
Page 2 of
Office of in Vitro Diagnostics a
510(k) K123622
10
510(k) Number (if known):
Device Name:
9L4
Indications for Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | P | P | P | | P | P | P | P* | P |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | P | P | P | P* | P |
| Laparoscopic | | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P* | P |
| Other (specify) | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Page 3 of
Page 3 of
Division of Radiological Health
Office of In Vitro Diagnostics and Radiologica
510(k) K123622
11
510(k) Number (if known):
Device Name:
V5M TEE
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | | P | |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | | P | |
| Trans-esophageal | | P | P | P | P | P | | | P* | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OlR) Prescription Use (Per 21 CFR 801.109)
Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Page 4 of
Division of Radiological Health
Office of In Vitro Diagnostics and Rac
510(k) K123622
12
510(k) Number (if known):
Device Name:
4V1c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179
510k
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
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Michael D. O'Hare
(Division Sign Off)
Page 5 of
(Division Sign Only)
Division of Radiological Health
Office of In Vitro Di ical Health
13
510(k) Number (if known):
Device Name:
8V3c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P * | P |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P * | P |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P * | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | | P | P | P | P | P | P | | P * | P |
N=new indication. Previously Cleared in 510(k) K102017, K113179
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
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Minh D. O'Kee
(Division Sign Off)
Division of Radiological Healt
Jitice of In Vitro Diagnostics and Radiological Health
510(k) K123622
14
510(k) Number (if known):
Device Name:
AUX CW2
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179
Additional Comments:
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Michael D'John
Page 7 of
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) K123622
15
510(k) Number (if known):
Device Name:
4Z1c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | | | P* | P | P |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| lntraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | P | P |
| Small Organ -
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | P | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Mhhel D.O.Thm
(Division Sign Off)
Page 8 of
Division of Radiological Health
Office of In V
5100 K123622
16
510(k) Number (if known):
Device Name:
AcuNav 8F and 10F Ultrasound Catheter
Intended Use:
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 as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | P | P | P | P | P | P | | P* | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-Cardiac) | | P | P | P | P | P | P | | P* | | |
N=new indication. P = Previously Cleared in 510(k) K071234, K093812, K113179
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Page 9 of
Division of Radiological He
Office of In V
510(k) K123622
17
510(k) Number (if known):
Device Name:
ACUSON AcuNav™ V 10F Ultrasound Catheter
Intended Use:
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 as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | | P |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | P |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | P |
N=new indication. P = Previously Cleared in 510(k) K081808, K113179
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
escription Use (Per 21 CFR 801.109)
(Division Sign Off)
Page 10 of
Division of Radiological He
Office of In Vitro Diagnostic
510(k) K123622
18
510(k) Number (if known):
Device Name:
SoundStar 10F Ultrasound Catheter
Intended Use:
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:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | |
N=new indication. P = Previously Cleared in 510(k) K070242, K113179
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Page 11 of
Division of Radiological Hess
Office of In Vitro Diagnostics
510(k) K123622
19
510(k) Number (if known):
Device Name:
V7M TEE
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P* | P | P |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | | P* | | P |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | | | P* | | P |
| Trans-esophageal | P | P | P | P | P | P | | | P* | | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| ·Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K111674
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 ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Michael D. Oker
Page 12 of __
(Division Sign Off) Division of Radiological Health
Office of In Vitro Diagnostics and Radiolo
: 510(K) K123622
20
510(k) Number (if known):
Device Name:
10V4
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P* | P | |
| Abdominal | P | P | P | P | P | P | P | P* | P | |
| Intraoperative
Abdominal | P | P | P | P | P | P | P | P* | P | |
| Intraoperative
Neurological | P | P | P | P | P | P | P | P* | P | |
| Pediatric | P | P | P | P | P | P | P | P* | P | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | P* | P | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | P | P | P | P | P | P | P | P* | P | |
N=new indication. Previously Cleared in 510(k) K111674
Additional Comments:
*Combinations include: B+M, B+PWD, 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
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
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Division of Radiological Health Office of In Vitro Diagnostics and Radiological
510(k) K123622