ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

K130754 · Siemens Medi Cal Solutions, Inc. · IYN · Mar 25, 2013 · Radiology

Device Facts

• Record ID: K130754
• Device Name: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 25, 2013
• 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, Intraoperative Abdominal, Intraoperative, 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

ACUSON SC2000 is a diagnostic ultrasound system; transmits ultrasound energy into body; creates 2D, 3D, M-Mode, Color Doppler, Color Power Doppler, Pulsed Wave, and Continuous Wave Doppler images. Inputs include ultrasound echoes and patient ECG for image synchronization. System supports various transducers and catheters for intra-cardiac/intraluminal visualization. Used in clinical settings by physicians; provides anatomical measurements and calculation packages. Output assists clinicians in evaluating pathology and guiding procedures. Benefits include non-invasive visualization of cardiac, vascular, and musculoskeletal structures; adjunctive diagnostic information for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data required as the modification involves only renaming existing transducers with no changes to device hardware, software, or intended use.

Technological Characteristics

Diagnostic ultrasound system; supports multiple imaging modes (2D, 3D, M-Mode, Doppler). Materials comply with ISO 10993-1. Safety standards include IEC 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3. Connectivity includes ECG synchronization. Transducers/catheters include 9L4, 8V3, V5Ms, 4V1c, CW2, 4Z1c, 10V4, AcuNav, and SoundStar models.

Indications for Use

Indicated for adult, pediatric, neonatal, and fetal cardiac patients; adult patients for vascular, superficial, intraoperative, and transcranial imaging. Used for visualization of anatomy, physiology, and blood flow velocity to evaluate pathology. Supports intra-cardiac and intraluminal visualization via catheters.

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 (K123622)

Reference Devices

• K072365
• K102017
• K113179
• K071234
• K093812
• K081808
• K070242
• K111674

Submission Summary (Full Text)

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ACUSON SC2000 Diagnostic Ultrasound System Special 510(k)

K130754
Page 1 of 3

# SECTION 11

MAR 2 5 2013

510(k) Summary Prepared March 6, 2013

Siemens Medical Solutions USA, Inc., Sponsor: Ultrasound Division 685 East Middlefield Road Mountain View, California 94043

Contact Person: Patrick Lynch Telephone: [phone]

March 6, 2013 Submission Date:

Modified Device Name: ACUSON SC2000 Diagnostic Ultrasound System

Diagnostic Ultrasound System Common Name:

#### Classification:

Regulatory 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-IYC |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code OBJ |

#### A. Legally Marketed Predicate Devices

The modified Diagnostic Ultrasound System is substantially equivalent to the company's previously cleared device (K123622).

#### B. Device Description:

The Acuson SC2000™ has been designed to meet the following product safety standards:

- UL 60601-1, Safety Requirements for Medical Equipment ■
- 제 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 1 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
- 해 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

#### C. Intended Use

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ACUSON SC2000 Diagnostic Ultrasound System Special 510(k)

K130754
Page 2 of 3

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, 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 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 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 of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic 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 Dooder (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Dopoler (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.

## D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics. This modification is intended only to rename three transducers, as described in the table below.

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K130754
Page 3 of 3

.

. :

.

:

:

ACUSON SC2000 Diagnostic Ultrasound System Special 510(k)

·

、

| Predicate<br>Device<br>(K123622) | Submission<br>Device |
|----------------------------------|----------------------|
| Current Name | Modified Name |
| 8V3c | 8V3 |
| V5M TEE | V5Ms |
| AUX CW2 | CW2 |

# E. Performance Data

・

No performance data required to support this modification, as there is no change to any hardware or software, or method of use.

.

:

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or branches extending upwards.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2013

Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K130754

Trade/Device Name: 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 18, 2013 Received: March 19, 2013

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson SC2000™ Diagnostic Ultrasound System, as described in your premarket notification:

## Transducer Model Number

| 9L4 | AcuNav 8F and 10F Ultrasound Catheter |
|------|----------------------------------------------|
| V5Ms | ACUSON AcuNavTM V 10F Ultrasound<br>Catheter |
| 4V1c | |
| 8V3 | SoundStar 10F Ultrasound Catheter |
| CW2 | V7M TEE |
| 4Z1c | 10V4 |

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sm.h.7)

for

Janine M. Morris 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): K130754

## 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 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 (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 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Page 2 of 14

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510(k) Number (if known):

Device Name: SC2000 Diagnostic Ultrasound System

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: 3D | Other: Real Time 3D |
|-------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|--------------------|-------------------------|-----------|---------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P | | P |
| Abdominal | | P | P | P | P | P | P | | P* | P | | |
| Intraoperative Abdominal | | P | P | P | P | P | P | | P* | P | | |
| Intraoperative Neurological | | P | P | P | | P | P | P | P* | P | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | P | P |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal 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 Conventional | | P | P | P | | P | P | P | P* | P | | |
| Musculo-skeletal Superficial | | P | P | P | | P | P | P | P* | P | | |
| Other (Neonatal Cardiac) | | P | P | P | P | P | P | | P* | P | | |
| Other (Intra-Cardiac) | | P | | P | P | P | P | | P* | | | P |

N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179, K123622

#### 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)

> Page 3 of

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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 | | | | | | | | | | |
| 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) K072365, K102017, K113179, K123622

#### 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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> Page 4 of 14

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## 510(k) Number (if known):

Device Name:

## VSM 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, K123622

#### Additional Comments:

______________________________________________________________________________________________________________________________________________________________________________

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWQ+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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## 510(k) Number (if known):

Device Name: .

## 4V1cc

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) K072365, K102017. K113179, K123622

## Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Cglor 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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> Page 6 of

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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 | | | | | | | | | | |
| 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, K123622

#### 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

{12}------------------------------------------------

# 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, K123622

#### Additional Comments:

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)

Page 8 of ___ 14______________________________________________________________________________________________________________________________________________________________

{13}------------------------------------------------

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) K072365, K102017, K113179, K123622

#### Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, J B+CWD+Power Doppler、B+Clarify VE

{14}------------------------------------------------

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 | | | | | | | | | | | | |
| 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) K071234, K093812, K113179, K123622

#### 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

{15}------------------------------------------------

510(k) Number (if known):

Device Name:

# ACUSON AcuNav™ V 10F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:

| Clinical<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 | | | | | | | | | | | |
| Transurethra! | | | | | | | | | | | |
| 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) K081808, K 113179, K 123622

#### 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

{16}------------------------------------------------

510(k) Number (if known):

Device Name:

## SoundStar 10F Ultrasound Catheter

Intended Use:

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

| Clinical<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* | | |
| 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-Cardiac) | | P | P | P | P | P | P | | P* | | |

N=new indication. P = Previously Cleared in 510(k) K070242, K 113179, K 123622

#### 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

{17}------------------------------------------------

510(k) Number (if known):

Device Name:

## V7M 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 | 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 |
| 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) K 111674, K 123622

## 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)

Page 13 of 14

{18}------------------------------------------------

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 |
| Abdominal | | P | P | P | P | P | P | | P * | P |
| Intraoperative<br>Abdominal | | 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 |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | |…