Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe training or test sets typically associated with AI/ML development. The description focuses on standard ultrasound technology and image processing.

Therapeutic

No
The device is described as a "multi-purpose diagnostic ultrasound system," and its intended use is for "ultrasound imaging or fluid flow analysis" and "measurement of anatomical structures that provide information that is used for clinical diagnosis purposes." None of these descriptions indicate a therapeutic function.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the system "provides information that is used for clinical diagnosis purposes." Additionally, the "Device Description" explicitly calls it a "multi-purpose diagnostic ultrasound system." The predicate devices also have "Diagnostic Ultrasound System" in their names.

SaMD (Software as a Medical Device)

No

The device description explicitly states "The ANTARES system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software," indicating it includes hardware components (the ultrasound system and accessories) in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "Ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to generate images and data.
Device Description: It's described as a "multi-purpose diagnostic ultrasound system". Ultrasound systems are used for imaging in vivo (within the living body).
Input Imaging Modality: The input is "Ultrasound", which is an imaging technique applied to the body.
Anatomical Site: The listed anatomical sites are all locations within the human body.

IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

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

Ultrasound imaging or fluid flow analysis of the human body as follows: CW2 Probe for use with ACUSON Antares, CW5 Probe for use with ACUSON Antares, C5-2 Curved Array Transducer for use with ACUSON Antares, CX5-2 Curved Array Transducer for use with ACUSON Antares, VF7-3 Linear Array Transducer for use with ACUSON Antares, EC9-4 Curved Array Transducer for use with ACUSON Antares, VFX9-4 Linear Array Transducer for use with ACUSON Antares, VF10-5 Linear Array Transducer for use with ACUSON Antares, VF13-5 Linear Array Transducer for use with ACUSON Antares, VFX13-5 Multi-D Array Transducer for use with ACUSON Antares, PX4-1 Phased Array Transducer for use with ACUSON Antares, CH6-2 Curved Array Transducer for use with ACUSON Antares, CH4-1 Curved Array Transducer for use with ACUSON Antares, PH4-1 Phased Array Transducer for use with ACUSON Antares, P10-4 Phased Array Transducer for use with ACUSON Antares, VF13-5SP Linear Array Transducer for use with ACUSON Antares Diagnostic Imaging or fluid flow analysis of the human body, C5F1 Curved array mechanical 3D transducer for use with ACUSON Antares, C7F2 Curved array mechanical 3D transducer for use with ACUSON Antares, EV9F4 Curved Array Transducer for use with ACUSON Antares, V5Ms Multiplane TEE Transducer for use with ACUSON Antares.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYC, 90-ITX

Device Description

The ANTARES system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Intraoperative, Small Parts (breast, testes, thyroid, penis, prostate, etc.), Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular, Fetal, Transrectal, Transvaginal

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063138, K050034, K033196

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

510(K) SUMMARY

063805
JAN - 5 2007

ACUSON ANTARES™ Diagnostic Ultrasound System

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:

Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird way Mountain View, CA 94043

Contact Person:

Michaela Mahl Regulatory Affairs Specialist Phone: (650) 694 5653 (650) 943 7053 FAX:

Date Prepared:

12/01/2006

2. Proprietary Name: ACUSON ANTARES™ Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

Requiatory Class: II Review Category: Tier II Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System:	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System:	FR # 892.1560	Product Code 90-IYC
Diagnostic Ultrasound Transducer:	FR # 892.1570	Product Code 90-ITX

3. Predicate Device:

K063138, 11/22/2006, ACUSON Antares™ Diagnostic Ultrasound System 트
트 K050034, 01/13/2005, SONOLINE Antares™ Diagnostic Ultrasound System
K033196, 10/16/2003, SONOLINE Antares™ with CLARIFY VE Diagnostic Ultrasound 포 System

Device Description: 4.

The ANTARES system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

The ACUSON ANTARES has been designed to meet the following product safety standards:

UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety .
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .

1

NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound .
NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output . Indices on Diagnostic Ultrasound Equipment
93/42/EEC Medical Devices Directive .
Safety and EMC Requirements for Medical Equipment .
EN 60601-1 .
. EN 60601-1-1
EN 60601-1-2 �
. EN 60601-1-2-37
EN 60601-1-4 �
IEC 61157 Declaration of Acoustic Power �
ISO 10993 Biocompatibility .
The system's acoustic output is in accordance with ALARA principle (as low as reasonably . achievable)

5. Intended Uses:

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, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

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

દ. Technological Comparison to Predicate Device:

The ACUSON ANTARES™ is substantially equivalent to the predicate devices listed in paragraph 3 above. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures to aid in diagnosis.

End of 510(k) Summary

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 5 2007

Re: K063803

Trade Name: ACUSON Antares Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 21, 2006 Received: December 22, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent(for the use 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 devises, or unc the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON Antares Diagnostic Ultrasound System as described in your premarket 100
notificatio notification:

Image /page/2/Picture/11 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a bold font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".

noting Public I

3

Transducer Model Number

CW2	PX4-1 Phased Array
CW5	CH6-2 Curved Array
C5-2 Curved Array	CH4-1 Curved Array
CX5-2 Curved Array	PH4-1 Phased Array
VF7-3 Linear Array	P10-4 Phased Array
EC9-4 Curved Array	VF13-5SP Linear Array
VFX9-4 Linear Array	C5F1 Curved Array Mechanical 3D
VF10-5 Linear Array	C7F2 Curved Array Mechanical 3D
VF13-5 Linear Array	EV9F4 Curved Array
VFX13-5 Multi-D Array	V5Ms Multiplane 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.

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

4

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

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

Sincerely yours.

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

Enclosure(s)

5

510 (k) Number (if known):

K063803

Device Name:

ACUSON Antares 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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
(Note 9)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Neurological		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,10
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously cleared by FDA - K063138, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SleClear multi-view spatial compounding

Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging (cardiac only)

B&W SieScape panoramic Imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology

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

Nancy C. Hogdon
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063803

6

510 (k) Number (if known): K063803

Device Name: Intended Use:

CW2 Probe for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial
Other (specify)

N = new Indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. For example: vascular, abdominal Note 9

Example: Pseudata/abdominal

(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 Roagdon

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

Section 4.3, Pg. 2 of 21

7

510 (k) Number (if known): K063803

Device Name: Intended Use:

CW5 Probe for use with ACUSON Antares

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034; E = added under Appendix E

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal

(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, and Radiological Devices 510(k) Number _

December 13, 2006

8

510 (k) Number (if known): K063803

Device Name: Intended Use:

C5-2 Curved Array Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D Imaging Note 5
B&W SieScape panoramic imaging Note 7

Note 8 Power SleScape panoramic Imaging

Note 10 Clarify VE vascular enhancement technology

(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 Shoagdon
(Division Sign-Off)

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

Section 4.3, Pg. 4 of 21

9

510 (k) Number (if known): K063803

Device Name: Intended Use: CX5-2 Curved Array Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SleClear multi-view spatial compounding

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic Imaging
Power SleScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

(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)

Harry C. Brogdon

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

10

510 (k) Number (if known): K063803

Device Name: Intended Use: VF7-3 Linear Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously deared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic Imaging
SteClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D Imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(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, A and Radiological Devices 510(k) Number __

11

510 (k) Number (if known): K063803

Device Name: Intended Use:

EC9-4 Curved Array Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

(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, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

T

12

510 (k) Number (if known): K063803

Device Name: Intended Use:

VFX9-4 Linear Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology

(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, Abdomina and Radiological Devices 510(k) Number

December 13, 2006

13

510 (k) Number (if known): K063803

Device Name:

Intended Use:

VF10-5 Linear Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

(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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number ___ j2063803

14

510 (k) Number (if known): K063803

Device Name: Intended Use: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

VF13-5 Linear Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology

(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 510(k) Number _

15

510 (k) Number (if known); K063803

Device Name: Intended Use: VFX13-5 Multi-D Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(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 Beagdon
(Division Sign-Off)

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

16

510 (k) Number (if known): K063803

Device Name: Intended Use: PX4-1 Phased Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethrai
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, 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

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging (cardiac only)

Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

(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 Crozlor
(Division Sign-Off)
Prescriptio

Division of Reproductive and Radiological Devices 510(k) Number

17

510 (k) Number (if known): K063803

Device Name: Intended Use:

CH6-2 Curved Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skelatal
Superficial
Other (specify)

N = new indication; P = previously deared by FDA - K050034, 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 imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

Prescription Use (Par 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)

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

18

510 (k) Number (if known): K063803

Device Name: Intended Use:

CH4-1 Curved Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic Imaging Note 8
Note 10 Clarify VE vascular enhancement technology

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

Nancy C Brogdon

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

December 13, 2006

Section 4.3, Pg. 14 of 21

19

510 (k) Number (if known): K063803

Device Name: Intended Use: PH4-1 Phased Array Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously deared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SfeClear multi view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic Imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(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 Chroydon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number L063803

Section 4.3, Pg. 15 of 21

20

510 (k) Number (if known): K063803

Device Name:

Intended Use:

P10-4 Phased Array Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

N = new Indication; P = previously cleared by FDA - K050034, 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 imaging

Note 6 Cadence contrast agent imaging (cardiac only)

Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic Imaging

Note 10 Clarify VE vascular enhancement technology

(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 $ign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063803

21

510 (k) Number (if known):

K063803

Device Name:

VF13-5SP Linear Array Transducer for use with ACUSON Antares Diagnostic Imaging or fluid flow analysis of the human body as follows:

Indications For Use:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(Note 9) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative
Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note S 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology

(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, A odomir and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

22

510 (k) Number (if known): K063803

Device Name: Intended Use: C5F1 Curved array mechanical 3D transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-fime 3D Imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology

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

Nancy broadlon
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
h

and Radiological Devices

December 13, 2006

23

510 (k) Number (if known): K063803

Device Name: Intended Use: C7F2 Curved array mechanical 3D transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034, K033196; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D Imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology

(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,

Radiological Devices K063803

(K) Number

24

510 (k) Number (if known): K063803

Device Name: Intended Use:

EV9F4 Curved Array Transducer for use with ACUSON Antares Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pedlatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K050034; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic Imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic Imaging
Power SieScape panoramic imaging 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 (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2063803

25

510 (k) Number (if known):

K063803

Device Name: Intended Use:

V5Ms Multiplane TEE Transducer for use with ACUSON Antares

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardlac
Trans-esophageal		P	P	P	P	P	P	BMDC	Note4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA - K063138; E = added under Appendix E

Additional Comments:

Note 4 Tissue Equalization Technology

(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. Bogdon
(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 5 FO(k) Number _______________________________________________________________________________________________________________________________________________________________

December 13, 2006

Section 4.3, Pg. 21 of 21