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 Description

The Siemens Acuson ANTARES MODIFICATION has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; 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; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens Antares Ultrasound System. It details modifications to the system and various transducers. However, it does not contain information about specific acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes, nor does it describe a study proving the device meets such criteria.

The document primarily focuses on:

Safety and EMC Requirements: The device (Siemens Acuson ANTARES MODIFICATION) is designed to meet various product safety standards (UL, IEC, CSA, AIUM/NEMA, EEC, ISO 10993-1). These are technical standards for electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than clinical performance metrics.
Intended Use: It lists numerous clinical applications for the ultrasound system and its various transducers.
Substantial Equivalence: The submission asserts that the device is substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics.
Performance Data (General Statement): It states, "The modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification." This is a general statement about their internal quality and design control processes, not a report of a specific clinical study with defined acceptance criteria and performance results.
Transducer-Specific Indications: Detailed tables show the modes of operation and specific clinical applications for each transducer model, indicating which applications were "previously cleared by the FDA" ("P") and which were "added under Appendix E" ("E").

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set, and how training set ground truth was established because this specific 510(k) summary does not contain that type of clinical performance study data or acceptance criteria.

The document is a regulatory submission demonstrating compliance with safety standards and substantial equivalence, not a clinical trial report.

Summary

{0}------------------------------------------------

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.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393
Contact Person:	Sheila W. Pickering
	Telephone: (650) 943 7187
	Fax: (650) 943 7053
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

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

. 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.

{2}------------------------------------------------

SECTION 11

510(k) Summary

Prepared 10/11/2006

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393
Contact Person:	Sheila W. Pickering
	Telephone: (650) 943 7187
	Fax: (650) 943 7053
Submission Date:	October 13, 2006
Device Name:	Siemens Antares Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: IIReview Category: Tier IIClassification 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.

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

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

{5}------------------------------------------------

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.

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

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Page 4-Sheila Pickering, Ph.D.

If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.

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)

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

SECTION 7 Intended Use of the Device

(ACUSON ANTARES ™ Ultrasound System)

Intended Use:

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

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

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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7
Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7
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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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 usewith:SIEMENS ACUSON ANTARES MODIFICATION UltrasoundSystem
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body asfollows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	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.

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Notc 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)

Nancyc Brogdon

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

2 of 6-30

{21}------------------------------------------------

510(k) Number (if known):

Device Name:

7.5L70 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(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
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletal (Superficial)		P	P	P		P	P		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.

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)

Nancy C. Hogdon
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Pg. 6.13 of 6.30

{22}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

LB5-2 Linear 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 4,5
Abdominal		P	P	P		P	P		BMDC	Note 4,5
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
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.

Note 1 For cxample: 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

(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)

Naveen C. Brogdon

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

and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{23}------------------------------------------------

510(k) Number (if known):

Device Name:

L10-5 Linear Array Transducer for use with:

SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System

Intended Usc:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Small Organ (Note 1)	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
Musculo-skeletal (Superficial)	P	P	P	P		P	P		BMDC	Note2,3,4,5,8
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)

Prescription Use (Per 21 CFR 801.109)

C
*ancy C. Brogd
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Diagnostic Ultrasound Use Form
K063138
Pg 6.15 of 6.30

{24}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P		BMDC	Note 3,4,5,8
Small Organ (Note 1)		P	P	P	P	P	P		BMDC	Note 3,4,5,8
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P	P	P	P		BMDC	Note 3,4,5,8
Musculo-skeletal (Superficial)		P	P	P	P	P	P		BMDC	Note 3,4,5,8
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
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. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K1663138

{25}------------------------------------------------

510(k) Number (if known):

Device Name:

VF13-5SP 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)		P	P	P		P	P		BMDC	Note 3,4,5,8
Intraoperative Neurological		P	P	P		P	P		BMDC	Note 3,4,5,8
Pediatric		P	P	P		P	P		BMDC	Note 3,4,5,8
Small Organ (Note 1)		P	P	P		P	P		BMDC	Note 3,4,5,8
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3,4,5,8
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		BMDC	Note 3,4,5,8
Musculo-skeletal Superficial		P	P	P		P	P		BMDC	Note 3,4,5,8
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

B&W SieScape panoramic imaging Note 4

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 I Concurrence of CDRH, Office of Device Evaluation (QDE Prescription Use (Per 21 CFR 80 Division of Reproductive and Radiological Devices 510(k) Number

{26}------------------------------------------------

510(k) Number (if known):

Device Name: 7.5L50I 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 3,4,5
Intraoperative (Note 6)		P	P	P		P	P		BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)		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		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		BMDC	Note 3,4,5
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

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) ﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

801.109)

(Division Sign-Off)

Nancy C Brogdon

Sign
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06313

Pg. 6.18 of 6.30

{27}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

7.51.500 Linear Array Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMDC	Note 3,4,5
Intraoperative (Note 6)		P	P	P		P	P		BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)		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		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P		BMDC	Note 3,4,5
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

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 Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number N063138

Diagnostic Ultrasound Indications for Use Form

Pg. 6.19 of 6.30

{28}------------------------------------------------

510(k) Number (if known):

Device Name:

8L3 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:

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P		BMDC	Note 2,3,4,5,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Small Organ (Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
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

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)

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

Diagnostic Ultrasound Indications for Use Form

Pg. 6.20 of 6.30

{29}------------------------------------------------

510 (k) Number (if known):

Device Name:

C7F2 Curved array mechanical 3D 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K033196; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaqinq

Note 7 B&W SieScape panoramic imaging

(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)

Yancy C. Brogdon
(Division Sign-Off)

Division of Reproduc and Radiological Devices 510kj Nomber

Pg. 6.21 of 6.30

{30}------------------------------------------------

510(k) Number (if known):

D. W.

Device Name:

LAP8-4 Laparoscopic Transducer for use with: SIEMENS ACUSON ANTARES MODIFICATION Ultrasound System

Intended Use:

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)	P	P	P	P	P	BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic	P	P	P	P	P	BMDC	Note 3,4,5
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

B&W SieScape panoramic imaging Note 4

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)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
40103128

Radiological Devices
510(k) Number K06313

{31}------------------------------------------------

510(k) Number ar known):

Device Name:

P4-2 Phased Sector 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P		BMDC
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,7
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.

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

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)

CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K063138

Diagnostic Ultrasound Indications for Use Form

Pg. 6.23 of 6.30

{32}------------------------------------------------

510(k) Number (if

known).

Device Name:

5.0P10 Phased Sector 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2
Abdominal		P	P	P	P	P	P		BMDC	Note 2
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2
Small Organ (Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,7
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.

Note 1 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. Brogdon

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

{33}------------------------------------------------

510(k) Number (if known).

Device Name:

MPT7-4 Phased Sector Array TEE 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3,7
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.

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

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 Reproducti ve. Abdor and Radiological Devices 510(k) Number

Pg. 6.25 of 6.30

{34}------------------------------------------------

510(k) Number (if known):

Device Name:

CW2 Continuous Wave Doppler 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
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.

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

Note 2 Ensemble tissue harmonic imaging

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)

801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0631

{35}------------------------------------------------

510(k) Number (f known):

Device Name:

CW5 Continuous Wave Doppler 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
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

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)

Prescription Use (Per 21 CFR 801.109) Diagnostic Ultrasound Indications for Use Form

Nancy C Burgdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063138

{36}------------------------------------------------

510(k) Number (if known).

Device Name:

P9-4 Phased Sector 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:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
	Ophthalmic
Fetal	P	P	P	P	P	P	P	P	BMDC	Note 2
Abdominal	P	P	P	P	P	P	P	P	BMDC	Note 2
Intraoperative (Note 6)
Intraoperative Neurological	P	P	P	P		P	P	P	BMDC	Note 2
Pediatric	P	P	P	P	P	P	P	P	BMDC	Note 2
Small Organ (Note 1)	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	BMDC	Note 2
Adult Cephalic	P	P	P	P	P	P	P	P
Cardiac	P	P	P	P	P	P	P	P	BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	P	BMDC	Note 2
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K050240; 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
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. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063130

{37}------------------------------------------------

510(k) Number (if known):

Device Name:

CH5-2 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note2,3,7,8
Abdominal		P	P	P		P	P		BMDC	Note2,3,7,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P		BMDC	Note2,3,7,8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,7,8
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K043016; 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

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)

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

{38}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form 510 (k) Number (if known):

Device Name:

Acuson Antares Diagnostic Ultrasound System

V5M TEE

Transducer: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other :HarmonicImaging	Other :3D
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N*	N	N
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N	N	N
Small Organ(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N*	N	N
Trans-esophageal		N	N	N	N	N	N		N*	N	N
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)***

N = new indication; P = previously cleared by FDA (K032114); E = added under Appendix E

Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+CWD+Color Doppler,

B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+M+Power Doppler

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

Prescription Use (Por 21 CFR 801.109)

(301.109)

(Division Sign-Off)
Division of Nancy C. Brogdon

Division of Reproductive, Abdon and Radiological Devices . Abdominand Radiological . and Radiological . 6.30 of Diagnostic Ultrasound Indications fobox(R)Wumber

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.