SIEMENS ACUSON X500 ULTRASOUND SYSTEM

K061980 · Siemens Medical Solutions USA, Inc. · IYN · Aug 17, 2006 · Radiology

Device Facts

• Record ID: K061980
• Device Name: SIEMENS ACUSON X500 ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Siemens Acuson X500 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic. Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletat, Great Vessel, and Peripheral Vascular applications.

Device Story

The Siemens Acuson X500 is a diagnostic ultrasound system designed for clinical imaging and fluid flow analysis. It processes acoustic signals received via various transducers (convex, linear, phased, and mechanical sector arrays) to produce real-time 2D, M-mode, and Doppler (PWD, CWD, Color, Amplitude) images. Used in clinical settings (e.g., radiology, cardiology, OB/GYN) by trained healthcare professionals, the system supports advanced imaging modes including Ensemble tissue harmonic imaging, 3D imaging, and panoramic imaging (SieScape). The system aids clinicians in diagnostic decision-making by providing anatomical and hemodynamic visualization. It complies with safety standards for acoustic output and thermal/mechanical indices, ensuring patient safety during diagnostic procedures.

Clinical Evidence

Bench testing only. The device was verified and validated according to the company's design control process, including compliance with safety standards (UL 60601-1, IEC 60601-2-37, ISO 10993-1). No clinical data was required for this 510(k) clearance.

Technological Characteristics

Diagnostic ultrasound system utilizing various transducer types (convex, linear, phased, mechanical sector). Connectivity includes standard ultrasound interfaces. Complies with UL 60601-1, IEC 60601-2-37, and ISO 10993-1 for biocompatibility. Features include Ensemble tissue harmonic imaging, 3D imaging, and panoramic imaging. Energy source is electrical; system is designed for clinical use.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis of the human body, including abdominal, fetal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal applications. Patient population includes adults and pediatrics. Prescription use only.

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

• Siemens Sonoline G60S ultrasound system

Submission Summary (Full Text)

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Kobl980

#### SECTION 11

#### 510(k) Summary

| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Sheila W. Pickering | |
| | Telephone: [phone] | |
| | Fax: [phone] | |
| Submission Date: | July 11, 2006 | |
| Device Name: | Siemens Acuson X500 Ultrasound System | |
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Classification: | | |
| Regulatory Class: | II | |
| 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 |

#### A. Legally Marketed Predicate Devices

The Siemens Acuson X500 Ultrasound system is substantially equivalent to the Siemens Sonoline G60S ultrasound system.

#### B. Device Description:

The Siemens Acuson X500 has been designed to meet the following product safety standards:

- 트 UL 60601-1, Safety Requirements for Medical Equipment
- 이 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 요 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 트 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 이 93/42/EEC Medical Devices Directive
- t Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC ୧୦୧01 - I
- . EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 IEC 1157 Declaration of Acoustic Power
- l ISO 10993-1 Biocompatibility

{1}------------------------------------------------

#### C. Intended Use

The Siemens Acuson X500 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic. Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletat, Great Vessel, and Peripheral Vascular applications.

#### D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

#### E. Performance Data

The X500 modifications are verified and validated according to the company's design control process.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 7 2006

Sheila Pickering, Ph.D. Senior Director of Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K061980

Trade Name: Siemens Acuson X500TM Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 11, 2006 Received: July 17, 2006

Dear Dr. Pickering:

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 Siemens Acuson X500™ Ultrasound System, as described in your premarket notification:

Image /page/2/Picture/11 description: The image is a black and white circular logo for the FDA Centennial. The logo includes the letters "FDA" in a bold, stylized font, with the word "Centennial" written in cursive underneath. The years "1906 - 2006" are displayed above the FDA letters. The logo is surrounded by text that curves along the circle's edge, and there are three stars below the word "Centennial".

Protecting and Promoting Public Health

{3}------------------------------------------------

#### Transducer Model Number

| C5-2 Convex Array |
|-----------------------------------------|
| C6-2 Convex Array |
| C8-5 Convex Array |
| 5.0C50+ Convex Array |
| C6-3 3D Mechanically Driven 3D Convex |
| Array |
| EV9-4 Convex Array Endovaginal |
| Endo-VII Mechanical Sector Endovaginal |
| Endo-V 3D Mechanical Sector Endovaginal |
| Ec9-4 Convex Array Endovaginal |
| BE9-4 Convex Array Endocavity |
| 5.0L45 Linear Array |
| 7.5L70 Linear Array |
| LB5-2 Linear Array |
| L10-5 Linear Array |

VF13-5 Linear Array VF13-5SP Linear Array 7.5L50I Linear Array 7.5L50Q Linear Array 8L3 Linear Array C7F2 Curved Array Mechanical 3D LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Array MPT7-4 Phased Sector Array TEE CW2 CW5 P9-4 Phased Sector Array CH5-2 Convex Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

{4}------------------------------------------------

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ralph Shuping at [phone].

Sincerely yours,

David h. Syzmm

Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure(s)

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## Diagnostic Ultrasound Indications for Use Form

Kob 11720

510(k) Number (if known):

Device Name:

## SIEMENS ACUSON X500™ Ultrasound System

Intended Use:

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | P | P | P | | P | P | | BMDC | Note 3 |
| Intraoperative Neurological | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,7 |
| Transesophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,7 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Laparoscopic | | P | P | P | | P | P | | BMDC | Note 3 |
| Musculo-skeletal (Conventional) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal (Superficial) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K052894) E = added under Appendix E.

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual Format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

productive

{6}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

Koblito

510(k) Number (if known):

Device Name:

Intended Use:

## C5-2 Convex Array Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note l

Ensemble tissue harmonic imaging Note 2

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 5
- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
- Note 8 Virtual format

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Hagerman

(Division Sign-Off) Division of Reproductive. Abde and Radiological Devic 510(k) Number _

{7}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Koleli To

Device Name:

C6-2 Convex Array Transducer for use with:

## SIEMENS ACUSON X500 Ultrasound System

Intended Use:

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7 |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note l

Note 2 Ensemble tissue harmonic imaging

- 3D imaging Note 3
Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> > Prescription Use (Per 21 CFR 801.109)

David R. Lessem

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devic 510(k) Number

Page 32 of 68

{8}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

KU61420 510(k) Number (if known):

Device Name:

Intended Use:

## C8-5 Convex Array Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | E | E | E | | E | E | | BMDC | Note 3,4,5,7 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Musculo-skeletal (Superficial) | | E | E | E | | E | E | | BMDC | Note 3,4,5 |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note I For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6 Note 7

Contrast agent imaging

Note 8 Virtual format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

09) David La Heyman

(Division Sign-Off) Division of Reproductive, A and Radiological Devic 510(k) Number

{9}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known).

1661980 5.0C50+ Convex Array Transducer for use with: Device Name:

# SIEMENS ACUSON X500 Ultrasound System

Intended Use:

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | E | E | E | E | E | E | | BMDC | Note 3,4,5 |
| Musculo-skeletal (Superficial) | | E | E | E | E | E | E | | BMDC | Note 3,4,5 |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

- Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

- Note 8 Virtual Format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number_

{10}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

| 510(k) Number (if known): | K061150 |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Device Name: | C6-3 3D Mechanically Driven 3D Convex Array Transducer for use with:<br>SIEMENS ACUSON X500 Ultrasound System |
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as follows: |

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | E | E | E | | E | E | | BMDC | Note 2,3,4,5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note I

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging Note 8 Virtual format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> > Prescription Use (Per 21 CFR 801.109)

Daniel A. Lynn

(Division Sign-Off) Division of Reproductive, Ab and Radiological Device 510(k) Number

{11}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

14061960

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note l

Note 2 Ensemble tissue harmonic imaging

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

- Note 8 Virtual format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Elmer A. Larson

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number

Page 36 of 68

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

#### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

1661180

Device Name:

Intended Use:

Endo-VII Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 3 |
| Abdominal | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 |
| Transvaginal | | P | P | | | | | | BM | Note 3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l For example: breast, testes, thyroid, penis, prostate, etc.

Ensemble tissue harmonic imaging Note 2

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

- Note 7 Contrast agent imaging
- Note 8 Virtual format

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lygren

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number .

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

#### Diagnostic Ultrasound Indications for Use Form

Kobigro 510(k) Number (if known):

Device Name:

Intended Use:

## Endo-V 3D Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 3 | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 | | | |
| Transvaginal | | P | P | | | | | | BM | Note 3 | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note I For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> > Prescription Usc (Per 21 CFR 801.109)

David Lynn

(Division Sign-Off) Division of Reproductive, Abe and Radiological Devices 510(k) Number

Page 38 of 68

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

#### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

11:01750

#### EC9-4 Convex Array Endovaginal Transducer for use with: Device Name: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as Intended Use: follows:

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

- Note 7 Contrast agent imaging
- Note 8 Virtual format

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

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

#### Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

11061982

Device Name:

Intended Use:

## BE9-4 Convex Array Endocavity Transducer for use with: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Abdominal | | | | | | | | | | |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

- Note 3 3D imaging
- Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

- Note 6 For example: abdominal, vascular
- Note 7 Contrast agent imaging
- Note 8 Virtual format

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David Bro. Lyman

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number

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

## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

5.0L45 Linear Array Transducer for use with:

061960

## SIEMENS ACUSON X500 Ultrasound System

Intended Use:

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Small Organ (Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5 |
| Musculo-skeletal (Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> > Prescription Use (Per 21 CFR 801.109)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .

Page 41 of 68

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

## Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

7.5L70 Linear Array Transducer for use with:

= 61980

## SIEMENS ACUSON X500 Ultrasound System

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

| | Mode of Operation | | | | | | | | | |
|---------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Note 6) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 3,4,5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | |…