ACUSON

K123622 · Siemens Medical Solutions USA, Inc. · IYN · Dec 5, 2012 · Radiology

Device Facts

• Record ID: K123622
• Device Name: ACUSON
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Dec 5, 2012
• 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, 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.

Device Story

The Acuson SC2000 is a mobile, software-controlled diagnostic ultrasound system. It acquires primary/secondary harmonic ultrasound echo data via various transducers (transthoracic/transesophageal/intracardiac catheters). Inputs include ultrasound signals and optional ECG for image synchronization. The system processes these to display B-Mode, M-Mode, Pulsed/Continuous/Color/Power Doppler, 3D, and 4D imaging. Operated by clinicians in clinical settings, the device provides anatomical measurements and calculation packages. Output is displayed on a flat-panel monitor to assist physicians in evaluating pathology and guiding intraoperative procedures. It benefits patients by providing non-invasive visualization of anatomy and physiology, supporting clinical diagnosis and procedural guidance.

Clinical Evidence

No clinical data was required for this submission. Substantial equivalence was established through bench testing, including safety and performance verification against recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-2/UD-3).

Technological Characteristics

Mobile ultrasound system; supports multiple transducers (phased array, TEE, intracardiac catheters). Imaging modes: B, M, PW/CW/Color/Power Doppler, 3D/4D, Harmonic. Connectivity: Wireless, DICOM (Print, Storage, Structured Reporting). Safety: EN60601-1, EN60601-2-37, ISO 10993-1. Software-controlled with workflow acceleration tools (eSie Measure, SpaceTime, TEQ).

Indications for Use

Indicated for adult, pediatric, neonatal, and fetal patients requiring ultrasound imaging or fluid flow analysis of cardiac, vascular, abdominal, neurological, and musculoskeletal structures. Contraindications: None stated.

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 (K113179)
• Acuson S2000 (K111674)
• Acuson X300 (K121699)

Reference Devices

• Acuson SC2000 (K072365)
• Acuson SC2000 (K102017)
• AcuNav 8F/10F (K071234, K093812)
• AcuNav V 10F (K081808)
• SoundStar 10F (K070242)

Submission Summary (Full Text)

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# 510(k) Summary Prepared October 18, 2012

DEC 0 5 2012

- 1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
- Contact Person: Patrick J. Lynch [phone] Telephone: [phone] 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)

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# 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.

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# 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<br>SC2000TM<br>K113179 | Acuson<br>S2000<br>K111674 | Acuson<br>X300<br>K121699 | Acuson<br>SC2000TM<br>This<br>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<br>capabilities and linking to MultiHertzTM multiple frequency<br>imaging | X | | | X |
| Integrated Stress echo capability | X | | | X |
| Cardiac imaging and quantification package | | | X | |
| DTI™ Doppler tissue imaging includes the following color<br>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<br>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<br>and High Resolution Color Flow (HRCF) | X | | X | |
| Cadence™ CPS Capture | X | | X | |
| Advanced SieClear™ spatial compounding with Dynamic TCE<br>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 |

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## 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.

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## 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),

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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 [phone].

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)

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## 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.

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### 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)

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Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)

Page 1 of

Muhal D. O'kin
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Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123622

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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 | | 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 | P | P | P | P | | P | P | | P* | P | | |
| 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 | |
| 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 |

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

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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

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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 | | P | P | P | | P | P | P | P* | P |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic<br>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<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) 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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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<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) 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)

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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<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<br>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) 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

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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<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<br>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) 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<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) 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<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 | | | | | | | | | | | |
| lntraoperative<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) 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<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 | | | | | | | |…