Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and post-processing techniques, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its function is to acquire and display data for "clinical diagnosis purposes," which indicates it is used for diagnosis rather than therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system "provides information that is used for clinical diagnosis purposes." Additionally, the "Device Description" characterizes the Antares as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software-controlled, diagnostic ultrasound system," indicating it includes hardware components (the ultrasound system itself) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is a "diagnostic ultrasound system." Ultrasound works by sending sound waves into the body and analyzing the echoes to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not in vitro (in glass/outside the body).
Intended Use: The intended uses listed all involve imaging or analyzing the human body directly (e.g., Fetal, Abdominal, Cardiac, Vascular). There is no mention of analyzing specimens taken from the body.

Therefore, the device described is a diagnostic imaging system, not an In Vitro Diagnostic device.

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: 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.

Ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Intraoperative (vascular, abdominal), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

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

90-IYN, 90-IYC, 90-ITX, 90 IYN, IYO, and ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative (vascular, abdominal), Pediatric, Small Organ (e.g., breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Intraoperative Neurological.

Indicated Patient Age Range

Not Found

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.

K001400, K003525

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.

K020353

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

K023720

510(K) SUMMARY

NOV 2 0 2002

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.

1. Submitted By:

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

Contact Person: Judi Hoffman Regulatory Affairs

Phone: (425) 557-1229 FAX: (425) 391-9198

Date Prepared: October 14, 2002

2. Proprietary Name:

. . .

: SONOLINE Antares Ultrasound System

Common/ Usual Name:
: Diagnostic Ultrasound System with Accessories

1

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-IYC
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:

B K001400, 8/1/00, cleared as the Elegra Millennium Advanced, marketed as the Antares
K003525, 11/22/00, cleared as the Voluson 730 Diagnostic Ultrasound System. marketed as the GE Voluson 730 4D

4. 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.

1

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

UL 2601-1. Safety Requirements for Medical Equipment
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and ■ Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
- EN 60601-1
- I EN 60601-1-1
- 피 EN 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993 Biocompatibility

5. Intended Uses:

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 with 4D Basic Imaging is substantially equivalent to the SONOLINE® Elegra Millennium Enhanced, cleared via K001400, and the Voluson 730 4D Diagnostic Ultrasound System, cleared via K003525. 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/13 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the symbol, and the word "DEPARTMENT" is at the bottom. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2002

Siemens Medical Solutions USA, Inc. % Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 25112-1891

Re: K023720

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: November 4, 2002 Received: November 5, 2002

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 your premarket notification:

Transducer Model Number

CW2 CW5 C5-2 Curved Array

3

Image /page/3/Picture/0 description: The image shows a list of different types of ultrasound transducers. The list includes CX5-2 Curved Array, 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, and C7F2 Curved Array Mechanical 3D. The transducers are categorized by their array type, such as curved, linear, phased, or multi-D.

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:

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours,

Karid A. Segern

for N.
Dr

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):

SONOLINE Antares

K001400

Device Name: Intended Use:

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

| 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 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
(Note 9) | | N | N | N | P | N | N | | BMDC | Note 2,3,4,5,7,8 |
| Intraoperative
Neurological | | N | N | N | | N | N | | 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-skeletal
Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8 |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8 |
| 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

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

For example: vascular, abdominal Note 9.

Per 21 CFR 801.109)

(Division Sign-Off)

Radiological Devices
510(k) Number

6

510 (k) Number (if known):

CW2 Probe for use with SONOLINE Antares

K001400

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	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; E = added under Appendix E

Additional Comments:

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

For example: vascular, abdominal Note 9

.

David G. Lippman

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

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:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					N
Abdominal					N
Intraoperative
(Note 9)					N
Intraoperative
Neurological
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-skeletal
Conventional					N
Musculo-skeletal
Superficial
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.

For example: vascular, abdominal Note 9

David A. Ligons

(Division Sign-Off) Division of Reproductive, Abdo Postedings: One

8

510 (k) Number (if known):

K001400

Device Name: Intended Use: C5-2 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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial
Other (specify)

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

Power SieScape panoramic imaging Note 8

David A. Siyom

and Ra 510(k) Numbe

9

510 (k) Number (if known):

Device Name:

Intended Use:

K001400

CX5-2 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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

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

David C. Heymann

(Division Sign-Off Division of Reproductive, Abdomin and Radioloo 510(k) Number

10

510 (k) Number (if known):

K001400

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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		E	E	E		E	E	BMDC	Note 2,3,4,5,7,8
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

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

Note 8 Power SieScape panoramic imaging

David A. Thompson

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

.

11

510 (k) Number (if known):

K001400

Device Name: Intended Use:

EC9-4 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		E	E	E		E	E	BMDC	Note 2,3,4,5,7,8
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

David A. Stegman

(Division Sian-Off) Division of Reproductive, Abdomi and Radiological Devic 510(k) Number

12

510 (k) Number (if known):

Device Name:

Intended Use:

K001400

VFX9-4 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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		E	E	E		E	E	BMDC	Note 2,3,4,5,7,8
Other (specify)

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

Power SieScape panoramic imaging Note 8

Daniel G. Lyon

Division Sign-Off) Sussion of Reproductive. Ab dimingical Devi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13

510 (k) Number (if known):

Device Name:

Intended Use:

K001400

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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Other (specify)

N = new indication; P = previously cleared by FDA; 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 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

David A. Bergman

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

14

510 (k) Number (if known):

K001400

Device Name: Intended Use: VF13-5 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Other (specify)

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

Einal A. Legum

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 51 (%) Number _

15

510 (k) Number (if known):

K001400

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
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.

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

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Daniel A. Lyon

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

16

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

K001400 (formerly cleared as PX5-2)

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	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
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Eurid G. Leyman

(Division Sion-Off) Division of Reproductive, Abdominal and Radiological Devices 10(k) Number -

17

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

K001400 (formerly cleared as M7-4) K020353 Omnia X/XS

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	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
Cardiac
Trans-esophageal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Eavid A. Sypm

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

18

510 (k) Number (if known):

K001400 (formerly cleared as C7-3)

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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

David A. Lyman

(Division Sign-Off) Division of Reproductive, Ahdominal ano Pladiological Devices 510(k) Number _

19

510 (k) Number (if known):

K001400 (formerly cleared as P3-2)

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	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		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Daniel A. Symm

(Division Sign-Off)

Basion of Reproductive, Abdominal,

Mediological Devices

Numbe

4023720

20

510 (k) Number (if known):

K001400 (formerly cleared as P9-4)

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

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

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Daniel A. Lam

(Division Sign-Off) Division of Reproductive, Abdo and Gadiological Devices 51 Wel Number

21

510 (k) Number (if known):

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

Device Name: Indications For Use: Diagnostic 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
(Note 9)		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Intraoperative
Neurological		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Pediatric		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Small Organ
(Note 1)		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
Musculo-skeletal
Superficial		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8
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.

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

Note 9 For example: vascular, abdominal

Daniel A. Lynn
(Division Sign-Off)

Owlsion of Reproductive, Abdomin ano Radiological Devices : " Yld Number

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

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

Daniel Li. Lynn

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

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

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Daniel Lissing

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K003120