Ultrasound imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, 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 Antares with 4D Basic Imaging is substantially equivalent to the predicates listed herein. The Antares is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, 3D imaging, and 4D Basic Imaging on a CRT display.

AI/ML Overview

The provided 510(k) summary for the Siemens SONOLINE Antares™ Diagnostic Ultrasound System does not contain information on the acceptance criteria or test study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data sample size, or training ground truth establishment.

Instead, the document focuses on:

Device Description: General purpose, mobile, software-controlled diagnostic ultrasound system with various imaging modes (B-Mode, M-Mode, PWD, CWD, Color Doppler, Amplitude Doppler, Harmonic Imaging, 3D, and 4D Basic Imaging).
Intended Uses: A broad range of clinical applications including General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Technological Comparison to Predicate Device: The Antares system is stated to be substantially equivalent to previously cleared devices (SONOLINE Elegra Millennium Enhanced, K001400; SONOLINE G50/G60 S, K040060) by performing similar functions of transmitting ultrasound, post-processing echoes, and displaying anatomical structures and fluid flow.
Compliance with Standards: The device has been designed to meet several product safety standards (UL, CSA, AIUM/NEMA, IEC, ISO, EN, and 93/42/EEC Medical Devices Directive).
FDA Clearance: The document includes the FDA's letter of clearance and several "Indications for Use Forms" for the main system and various transducers, listing the clinical applications and modes of operation for which each is cleared.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the various aspects of a study (sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth) as this information is not present in the provided text. The submission primarily relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards rather than providing detailed clinical study results with specific performance metrics.

Summary

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

JAN 1 3 2005 510(K) SUMMARY

Antares Diagnostic Ultrasound System with 4D Basic Imaging

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.

Submitted By: 1.

Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98027-7298

Contact Person: Patrick Lynch Regulatory Affairs

Phone: (425) 557-1825 FAX: (425) 391-9198

Date Prepared:

December 22, 2004

Proprietary Name: SONOLINE Antares™ Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550
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

3. Predicate Device: ·

The Antares system is multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the following products which are already cleared for US distribution with the following 510(k) clearances:

K001400, 8/1/00, cleared as the Elegra Millennium Advanced, marketed as the ■ Antares
K040060, 01/28/04, cleared as SONOLINE G50/G60 S Diagnostic Ultrasound ■ System

4. Device Description:

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

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

제 UL 60601-1, Safety Requirements for Medical Equipment
트 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
AIUM/NEMA UD-2. 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
l 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
- 에 EN 60601-1
- . EN 60601-1-1
- 비 EN 60601-1-2
트 IEC 1157 Declaration of Acoustic Power
ISO 10993 Biocompatibility ■

Intended Uses: 5.

The Antares ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, 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.

6. Technological Comparison to Predicate Device:

Antares Avant is substantially equivalent to the SONOLINE Elegra Millennium Enhanced. cleared via K001400, and the SONOLINE G50/G60 S Diagnostic Ultrasound System, cleared via K040060. All systems transmit ultrasonic energy into patients, then perform postprocessing 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 and flow, and calculations.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2005

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

Re: K050034

Trade Name: SONOLINE 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: 90 IYN, IYO, and ITX Dated: January 5, 2005 Received: January 7, 2005

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 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 SONOLINE Antares™ Diagnostic Ultrasound System, as described in vour premarket notification:

Transducer Model Number

CW2 CW5

C5-2 Curved Array CX5-2 Curved Array

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

VF7-3 Linear Array EC9-4 Curved Array VFX9-4 Linear Array VF10-5 Linear Array VF13-5 Linear Array VFX13-5 Multi-D Array PX4-1 Phased Array MPT7-4 Multiplane TEE

CH6-2 Curved Array PH4-1 Phased Array P10-4 Phased Array VF13-5SP Linear Array C5F1 Curved Array C7F2 Curved Array EV9F4 Curved Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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:

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.

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

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

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}------------------------------------------------

FDA Cleared Indications for Use Forms

510 (k) Number (if known):

Device Name: Intended Use:

SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Intraoperative(Note 9)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8
Trans-esophageal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

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 Sig. Off)

Division of Reproductive. Aticionins

and Radiological Dry

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

510 (k) Number (if known):

CW2 Probe for use with SONOLINE Antares

Device Name: 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
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological
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-skeletalConventional					P
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

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

For example: vascular, abdominal Note 9

Nancy C Brogdon

(Division Sign Division of Reproductive, Abdom and Radiological Devices

510(k) Number KD50034

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

510 (k) Number (if known):

CW5 Probe for use with SONOLINE Antares

Device Name: Intended Use:

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

Ultrasound imaging of 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					N
Abdominal					N
Intraoperative(Note 9)					N
IntraoperativeNeurological
Pediatric					N
Small Organ(Note 1)					N
Neonatal Cephalic					N
Adult Cephalic					N
Cardiac					N
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					N
Laparoscopic
Musculo-skeletalConventional					N
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

. .

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

For example: vascular, abdominal Note 9

Nancy Royston
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K050034

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

510 (k) Number (if known):

C5-2 Curved Array Transducer for use with SONOLINE: Antares

Device Name: 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Nancy C. Langdon

(Division Sigh-O Division of Reproductive, Abdom and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

CX5-2 Curved Array Transducer for use with SONOLINE Antares ::

Device Name: 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Nancy Thompson

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

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

VF7-3 Linear Array Transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Small Organ(Note 1)		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Nancy Snowdon

(Division Sign-Off) Division of Reproductive, Abdominal,

Radiological Devices
510(k) Number K050034

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

510 (k) Number (if known):

EC9-4 Curved Array Transducer for use with SONOLINE Antares

Device Name: Intended Use: ECS:4 Curved Array Transador 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		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

Street (open);
N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Nancy C Hodgson

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

12/22/2004

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

510 (k) Number (if known):

VFX9-4 Linear Array Transducer for use with SONOLINE Antares

Intended Use:

Device Name:

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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

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

Prescription Use (Per 21 CFR 801.109)

Nancy C. Snowdon

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

510(k) Number .

12/22/2004

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

510 (k) Number (if known):

Device Name:

Intended Use:

VF10-5 Linear Array Transducer for use with SONOLINE Antares

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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices

510(k) Number K050034

. !

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

510 (k) Number (if known):

VF13-5 Linear Array Transducer for use with SONOLINE Antares

Device Name: 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		E	E	E			E	E	BMDC	Note 2,3,4,5,7,8
Abdominal		E	E	E			E	E	BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P			P	P	BMDC	Note 2,3,4,5,7,8
Small Organ(Note 1)		P	P	P			P	P	BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		E	E	E			E	E	BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P			P	P	BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P			P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		P	P	P			P	P	BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

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

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

VFX13-5 Multi-D Array Transducer for use with SONOLINE Antares

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		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Abdominal		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		E	E	E		E	E		BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

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

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdomin

Radiological Devices

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

PX4-1 Phased Array Transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Nancy C. Broadlon

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

510(k) Number K650034

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

510 (k) Number (if known):

Device Name: Intended Use:

MPT7-4 Multiplane TEE Transducer for use with SONOLINE Antares 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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

Note 6 Cadence contrast agent imaging

Nancy brogdon

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

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

CH6-2 Curved Array Transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Nancy C. Brogdon

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

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

510 (k) Number (if known):

Device Name: Intended Use: PH4-1 Phased Array Transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K001400; E = added under Appendix E

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi view spatial compounding Note 3

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

Nancy Thompson

(Division Sign Off)

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

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

: .

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: P10-4 Phased Array Transducer for use with SONOLINE Antares 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	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P
Musculo-skeletalSuperficial									BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA K001400; 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

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Nancy C. Boydon

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

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Indications For Use:

VF13-5SP Linear Array Transducer for use with SONOLINE: Antares

Diagnostic 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 9)	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
IntraoperativeNeurological	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Pediatric	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Small Organ(Note 1)	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletalSuperficial	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA 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

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

For example: vascular, abdominal Note 9

(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)

Danaye brondon

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

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

C5F1 Curved array mechanical 3D transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic										Note 2,3,4,5,7,8
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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

SieClear multi-view spatial compounding Note 3

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

Dougal Brogdon

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

510(k) Number K050034

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

510 (k) Number (if known):

Device Name: Intended Use:

C7F2 Curved array mechanical 3D transducer for use with SONOLINE Antares 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 2,3,4,5,7,8
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8
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 imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Nancy Brogdon

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

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

510 (k) Number (if known):

Device Name: Intended Use:

EV9F4 Curved Array Transducer for use with SONOLINE Antares 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		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA; 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

Nancyc brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050034

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.