Acuson SC2000 Diagnostic Ultrasound System
Device Facts
| Record ID | K170315 |
|---|---|
| Device Name | Acuson SC2000 Diagnostic Ultrasound System |
| Applicant | Siemens Medi Cal Solutions, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 4, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, 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.
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires primary/secondary harmonic ultrasound echo data. Operates in B-mode, M-mode, Pulsed/Continuous Wave Doppler, Color Doppler, Amplitude Doppler, Color Velocity Imaging, 3D, and 4D (real-time 3D) modes. Used in clinical settings by physicians/clinicians for diagnostic imaging and guidance during intraoperative procedures. Transmits ultrasound energy into patient; synchronizes image capture with ECG. Supports specialized catheters for intra-cardiac/intraluminal visualization. Outputs images and blood flow velocity measurements to on-screen display. Provides measurement/calculation packages for adjunctive clinical diagnosis. Benefits include non-invasive visualization of anatomy/physiology and pathology evaluation.
Clinical Evidence
No clinical data required; substantial equivalence established via bench testing and adherence to recognized safety standards (AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62366, IEC 62304, NEMA UD-2, NEMA UD-3, ISO 10993-1).
Technological Characteristics
Mobile ultrasound system; matrix, phased, linear, and curved array transducers. Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity, 3D/4D. Connectivity: Wireless, DICOM. Safety: Thermal/mechanical indices display. Software: IEC 62304 compliant. Sterilization: Compatible with standard cleaning/disinfection protocols.
Indications for Use
Indicated for adult, pediatric, neonatal, and fetal patients requiring ultrasound imaging of cardiac, vascular, musculoskeletal, intraoperative, and transcranial structures to evaluate pathology. Contraindications not specified.
Regulatory Classification
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.
Predicate Devices
- ACUSON SC2000 Diagnostic Ultrasound System (K162221)
Related Devices
- K113179 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Dec 7, 2011
- K171766 — Acuson SC2000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Jul 12, 2017
- K180039 — ACUSON P600 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018
- K162221 — ACUSON SC2000 Diagnostic Ultrasound System · Siemens Medical Solutions Inc. Ultrasound Group · Sep 6, 2016
- K040060 — SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS · Siemens Medical Solutions USA, Inc. · Jan 28, 2004
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by a flowing line. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K170315
Trade/Device Name: Acuson SC2000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: March 27, 2017 Received: March 28, 2017
Dear Mr. Job:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
#### K170315
#### Device Name
Acuson SC2000TM Diagnostic Ultrasound System
#### Indications for Use (Describe)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, 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, pediativ, 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 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 arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for 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 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 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.
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Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
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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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | | P |
| Abdominal | | P | P | P | P | P | P | | P * | P | P | |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P * | P | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P | P |
| Small Organ<br>(specify) | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | P | P |
| Trans-esophageal | | P | P | P | P | P | | | P* | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | | P | P | P | P | P | P | | P* | | | P |
| Peripheral Vessel | | P | P | P | P | P | P | P | P* | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P* | P | | |
| Musculo-skeletal<br>Superficial | | P | P | P . | | P | P | P | P* | P | | |
| Other (Neonatal<br>Cardiac) | | P | P | P | P | P | P | | P* | P | | |
| Other (Intra-<br>Cardiac) | ਿ | P | P | P | P | P | P | | P* | | | P |
| Other<br>(Abdominal<br>Vascular) | | P | P | P | P | P | P | | P* | P | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### 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
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510(k) Number (if known):
Device Name: CW2
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication. Previously Cleared in 510(k) K162221
#### Additional Comments: 11
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### 510(k) Number (if known):
Device Name:
4Z1c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | | | P* | P | P |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | P | P |
| Small Organ<br>(specify) ** | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | P | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### 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
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### 510(k) Number (if known):
Device Name:
4V1c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Neonatal<br>Cardiac) | | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K16221
#### 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
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### 510(k) Number (if known):
Device Name:
V5Ms
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | | P* | | P |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### 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
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### 510(k) Number (if known):
Device Name:
#### 6C1HD
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify) | | P | P | P | P | P | P | | P* | P |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other<br>(Abdominal<br>Vascular) | | P | P | P | P | P | P | | P* | P |
N=new indication. P = Previously Cleared in 510(k) K162221
#### 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
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### 510(k) Number (if known):
Device Name:
Z6Ms
网
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | | | P* | P | P |
| Trans-esophageal | P | P | P | P | P | P | | | P* | P | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### 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
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### 510(k) Number (if known):
Device Name:
V7M
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | | P |
| Small Organ<br>(specify) | | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{12}------------------------------------------------
8V3
### 510(k) Number (if known):
Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P * | P |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P * | P |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Neonatal<br>Cardiac) | P | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K16221
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
9L4
Indications for Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | P | P | P | P | | P | P | P | P* | P |
| Laparoscopic | P | P | P | P | | P | P | P | | P |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | P | P* | P |
| Other (specify) | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{14}------------------------------------------------
### 510(k) Number (if known):
· Device Name:
10V4
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P* | P |
| Abdominal | P | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | P | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Neonatal<br>Cardiac) | P | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K162221
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
AcuNav 8F and 10F Ultrasound Catheter
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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | | |
| Small Organ<br>(specify) ** | | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Intra-<br>Cardiac) | | P | P | P | P | P | P | | P* | | |
N=new indication. P = Previously Cleared in 510(k) K 162221
#### 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 A SEPARATE PAGE IF NEEDED)
{16}------------------------------------------------
#### 510(k) Number (if known):
Device Name:
Intended Use:
### ACUSON AcuNav™ V 10F Ultrasound Catheter
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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | | P |
| Small Organ<br>(specify) ** | | | | | | | | | | | |
| Neonatal<br>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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Intra-<br>Cardiac) | P | P | P | P | P | P | P | | P* | | P |
N=new indication. P = Previously Cleared in 510(k) K 162221
#### Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{17}------------------------------------------------
#### 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:
a a
| Clinical<br>Application | A | B | M | PWD…
