MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM

K063138 · Siemens Medical Solutions USA, Inc. · IYN · Nov 22, 2006 · Radiology

Device Facts

• Record ID: K063138
• Device Name: MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Acuson Antares 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 Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

Siemens Acuson Antares is a diagnostic ultrasound system; utilizes various transducers (convex, linear, phased, TEE) to acquire acoustic data from human body; transforms signals into B-mode, M-mode, PWD, CWD, Color Doppler, and 3D images; used in clinical settings (e.g., OR, clinic) by physicians/technicians; provides anatomical measurements and analysis packages for clinical diagnosis; supports advanced imaging modes like Ensemble tissue harmonic imaging, SieScape panoramic imaging, and contrast agent imaging; aids healthcare providers in visualizing internal structures and blood flow to facilitate clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Modifications were verified and validated according to the company's design control process. Acoustic output measurements were performed in accordance with AIUM/NEMA UD-2 and UD-3 standards.

Technological Characteristics

Diagnostic ultrasound system; supports multiple transducer types (convex, linear, phased, TEE); complies with UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, and ISO 10993-1 biocompatibility standards; features include Ensemble tissue harmonic imaging, 3D imaging, and SieScape panoramic imaging; energy source is electrical; connectivity and software details are consistent with standard diagnostic ultrasound platforms.

Indications for Use

Indicated for ultrasound imaging or fluid flow analysis of the human body in clinical applications including abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, and musculoskeletal. 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

• Antares Diagnostic Ultrasound System (K052894, K033196, K023729)
• Siemens V5M Transesophageal Transducer (K052021)
• GE Hitachi EUB 8500 with Sonoelastography (K011252)

Submission Summary (Full Text)

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K 063/38

Antares Ultrasound System Special 510(k) Submission

# SECTION 11

#### 510(k) Summary

#### Prepared 10/11/2006

NOV 2 2 2006

| 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: | October 13, 2006 |
| Device Name: | Siemens Antares Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tier II |

| 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

Radiology

The Siemens Antares Ultrasound system is substantially equivalent to the following:

- . K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System
- . K052021, 8/17/2005, Siemens V5M Transesophageal Transducer
- K011252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography .

#### B. Device Description:

Classification Panel:

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

- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 들 AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 8 93/42/EEC Medical Devices Directive

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- . Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- 트 EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- 프 IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility

#### C. Intended Use

The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, 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 modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification.

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### SECTION 11

#### 510(k) Summary

#### Prepared 10/11/2006

| 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: | October 13, 2006 |
| Device Name: | Siemens Antares Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | Regulatory Class: II<br>Review Category: Tier II<br>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 Antares Ultrasound system is substantially equivalent to the following:

- . K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System
- · K052021, 8/17/2005, Siemens V5M Transesophageal Transducer
- . K011252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography

#### B. Device Description:

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

- UL 60601-1, Safety Requirements for Medical Equipment
- 해 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- l AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 제 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- l 93/42/EEC Medical Devices Directive

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

- 트 Safety and EMC Requirements for Medical Equipment
- 비 EN/IEC 60601-1
- I EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- I IEC 1157 Declaration of Acoustic Power
- 트 ISO 10993-1 Biocompatibility

#### C. Intended Usc

The Antares 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, Transsophagean, Fedric, 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 modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, human services, and well-being. 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

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

NOV 2 2 2006

Re: K063138

Trade Name: Siemens ACUSON Antares Modification™ 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 IYX Dated: October 13, 2006 Received: October 23, 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 Antares Modification™ Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2 Convex Array C6-2 Convex Array

Image /page/4/Picture/13 description: The image is a circular seal with the text "1906 - 2006" at the top. In the center of the seal is the acronym "FDA" in large, bold letters, with the word "Centennial" written below it in a smaller font. The seal is surrounded by text that appears to be the name of an organization or institution. There are also three stars at the bottom of the seal.

*Protecting and Promoting Public Health*

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Page 2-Sheila Pickering, Ph.D.

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 LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Array MPT7-4 Phased Sector Array TEE CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler P9-4 Phased Sector Array CH5-2 Convex Array V5M TEE

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

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Page 3-Sheila Pickering, Ph.D.

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:

> 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

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Page 4-Sheila Pickering, Ph.D.

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

Sincerely yours,

Nancy C Brogdon

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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# SECTION 7

# Intended Use of the Device

# (ACUSON ANTARES ™ Ultrasound System)

#### Intended Use:

The Acuson Antares 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 Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

*Prescription Use*

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdon and Radioloma: Devices 570gu mumber

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510(k) Number (if known):

Device Name:

# SIEMENS ACUSON ANTARES MODIFICATION TM 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 | P | | BMDC | Note 3 |
| Intraoperative Neurological | | P | 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 | P | | BMDC | Note 2,3,4,5 |
| Transvaginal | | P | 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 | 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.

Note 2 Ensemble tissue harmonic imaging

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

(IPLEASE 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

Nancy Chroydon

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

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

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

Device Name:

Intended Use:

C5-2 Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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.

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

B&W SieScape panoramic imaging Note 4

- 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)

Nancy C. Brogdon

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

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

510(k) Number (if known).

Device Name: C6-2 Convex Array Transducer for use with:

# SIEMENS ACUSON ANTARES MODIFICATION 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 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

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063/38
Indications for Use Form of 6.30
Pg. 6.3

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

# 510(k) Number (if

known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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 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

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)

Nancy C. Bergdon

(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices

Diagnostic Ultrasound Indication Olymper

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

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

Device Name:

# 5.0C50+ Convex Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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 | 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.

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
- 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)

Prescription Use (Per 21 CFR 801.109)

Nancy Chrooden

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K06 3138
Po. 6.5 of 6.30

Diagnostic Ultrasound Indications For K

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

510(k) Number (if known):

| Device Name: | C6-3 3D Mechanically Driven 3D Convex Array Transducer for use<br>with:<br>SIEMENS ACUSON ANTARES MODIFICATION Ultrasound<br>System |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as<br>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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

- Note 7 Contrast agent imaging
Virtual format Note 8

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

> > Prescription Use (Pcr 21 CFR 801.109)

Nancy Bergdon

(Division Sic Division of Reproductive, Abde diological Devices and Ra

Section 6

Diagnostic Ultrasound Indication

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

510(k) Number (if known).

Device Name:

EV9-4 Convex Array Endovaginal Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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 (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.

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
- Note 5 Power SieScape panoramic imaging
- 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)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Bowadon
Division Sign Off

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

Section 6

Diagnostic Ultrasound Indications for Use Form

Pg. 6.7 of 6.30

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

510(k) Number (if known):

Endo-VII Mechanical Sector Endovaginal Transducer for use with: Device Name: SIEMENS ACUSON ANTARES MODIFICATION 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 | | | | | | 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 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

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)

Nancy C. hogdon
(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

Diagnostic Ultrasound Indications for Use Form

Pg. 6.8 of 6.30

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

510(k) Number (if known):

Device Name:

Intended Use:

Endo-V 3D Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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.

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note S 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 Use (Per 21 CFR 801.109)

Nancy C. Hogdon

---

(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number

g. 6.9 of 6.30

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

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

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

| | 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.

follows:

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

Ensemble tissue harmonic imaging Note 2

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

Note 5 Power SieScape panoramic imaging

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)

> > Prescription Use (Per 21 CFR 801.109)

Nancy C. Hodgson

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

Pg. 6.10 of 6.30

{19}------------------------------------------------

510(k) Number (if known).

Device Name:

BE9-4 Convex Array Endocavity Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION 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 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

- 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 (Pcr 21 CFR 801.109)

(Division Sign-Off)
Nancy C. Brogdon
Division of Reproductive, Abdominal,
and Radiological Devices 1/063138

510(k) Number Diagnostic Ultrasound Indications for Use Form

Pg. 6.11 of 6.30

{20}------------------------------------------------

510(k) Number (if known):

Device Name:

5.0L45 Linear Array Transducer for use with:

# SIEMENS ACUSON ANTARES MODIFICATION 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 | 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…