ACUSON SC2000 Diagnostic Ultrasound System
Device Facts
| Record ID | K181098 |
|---|---|
| Device Name | ACUSON SC2000 Diagnostic Ultrasound System |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | May 31, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| 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, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Story
The ACUSON SC2000 is a mobile, software-controlled diagnostic ultrasound system. It transmits and receives ultrasound energy via transducers and catheters to generate 2D (B-mode), 3D, M-mode, Pulsed Wave (PW), Continuous Wave (CW), Color Doppler, and Color Power Doppler images. The system acquires ECG signals for image synchronization. It includes measurement and calculation packages for clinical diagnosis. A new optional joystick remote control allows clinicians to trigger control panel and cursor events within the sterile field during interventional procedures. The system supports various transducers and intracardiac echocardiography (ICE) catheters, including third-party SoundStar eco catheters via a SwiftLink connector. The device is used in clinical settings by physicians to evaluate pathology, guide interventional procedures, and provide anatomical measurements. It benefits patients by providing non-invasive diagnostic imaging and real-time guidance during cardiac interventions.
Clinical Evidence
No clinical data was required. Substantial equivalence was established through non-clinical bench testing, including acoustic output measurements, biocompatibility (ISO 10993-1), and electrical/electromagnetic safety (IEC 60601 series).
Technological Characteristics
Multi-purpose diagnostic ultrasound system. Materials tested to ISO 10993-1. Frequencies: 1.7MHz–10MHz. Modes: B, M, PWD, CWD, Color Doppler, CPD, Harmonic Imaging. Connectivity: DICOM, DICOM SR, Wireless. Software: Proprietary, v5.1. Safety: UL 60601-1, IEC 60601-1, IEC 60601-2-37, IEC 60601-2-18. Features: eSie Measure, eSie VVI, TrueFusion, TEQ, joystick remote control, SwiftLink connector.
Indications for Use
Indicated for adult, pediatric, neonatal, and fetal patients for cardiac, vascular, superficial, intraoperative, and transcranial ultrasound imaging. Used for visualization of anatomy, physiology, and blood flow velocity to evaluate pathology. Catheters are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart during interventional percutaneous procedures.
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, v5.0 (K171766)
- ACUSON AcuNav+ Volume Intracardiac Echocardiography (ICE) Catheter (K173618)
Reference Devices
- SoundStar eco 8F/10F (K140318)
- SoundStar 8F/10F (K112050)
- SoundStar eco 8F/10F (K163396)
- AcuNav Volume ICE Catheter (K170992)
Related Devices
- K162221 — ACUSON SC2000 Diagnostic Ultrasound System · Siemens Medical Solutions Inc. Ultrasound Group · Sep 6, 2016
- K142628 — Acuson SC2000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Oct 10, 2014
- K123622 — ACUSON · Siemens Medical Solutions USA, Inc. · Dec 5, 2012
- K130754 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medi Cal Solutions, Inc. · Mar 25, 2013
- K233613 — ACUSON SC2000 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jun 12, 2024
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 31, 2018
Siemens Medical Solutions USA, Inc % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K181098
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: May 24, 2018 Received: May 25, 2018
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. Iisting 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 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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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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Barlupo
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
1
## K181098
Device Name
ACUSON SC2000 Diagnostic Ultrasound System
### Indications for Use (Describe)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heail, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchromizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Dopler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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Prescription Use (Part 21 CFR 801 Subpart D)
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3
# Diagnostic Ultrasound Indications for Use Form (Per Appendix G, FDA Ultrasound Guidance)
510(k) Number (if known): K181098
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 | | P | |
| Abdominal | P | 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 | P | P | |
| Small Organ<br>(specify) | | | | | | | | | | | | | |
| Neonatal<br>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* | | 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<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 (Neonatal<br>Cardiac) | P | P | P | P | P | P | P | | P* | P | | | |
| Other (Intra-<br>Cardiac) | P | P | P | P | P | P | P | | P* | | | | P |
| Other<br>(Abdominal<br>Vascular) | P | P | P | P | P | P | P | | P* | P | | | |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
### 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): K181098
CW2 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 | | | | | | | | | | |
| 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, K170315, K171766
### Additional Comments:
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4Z1c
# 510(k) Number (if known): K181098
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 | Other:<br>Real<br>Time<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| 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 (specify) | | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
#### 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): K181098
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 * | 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 | P | P | P | P | P | P | P | | P * | P |
| 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, K170315, K171766
#### 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): K181098
Device Name: VSMs
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 |
| 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, K170315, K171766
#### 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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6C1HD
#### 510(k) Number (if known): K181098
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 | P | P | P | P | P | P | P | | P* | P |
| Intraoperative<br>Abdominal | P | P | P | P | P | P | P | | P* | P |
| Intraoperative | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | P |
| Small Organ<br>(specify) | P | 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* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other<br>(Abdominal<br>Vascular) | P | P | P | P | P | P | P | | P* | P |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
#### 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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Z6Ms
## 510(k) Number (if known): K181098
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 | 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, K170315, K171766
#### 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)
{11}------------------------------------------------
V7M
#### 510(k) Number (if known): K181098
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 | Other:<br>3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P* | P | P |
| 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 | 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, K170315, K171766
#### 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): K181098
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 |
| 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 (Neonatal<br>Cardiac) | | P | P | P | P | P | P | | P* | P |
N=new indication. Previously Cleared in 510(k) K162221, K170315, K171766
### 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}------------------------------------------------
9L4
510(k) Number (if known): K181098
Device Name:
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 |
| 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 (specify) | | | | | | | | | | |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
#### 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}------------------------------------------------
10V4
#### 510(k) Number (if known): K181098
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 | 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 | | | | | | | | | | |
| Cephalic<br>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, K170315, K171766
### 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): K181098
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<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* | | |
| 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 | | 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* | | |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
### 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): K181098
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<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 |
| 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 | | 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 |
N=new indication. P = Previously Cleared in 510(k) K162221, K170315, K171766
#### 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+Clar…
