The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Device Description

The GE Vivid S5/S6 is a mobile ultrasound console having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular a and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Vivid S5/S6 Diagnostic Ultrasound system, dated July 18, 2007. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information requested regarding acceptance criteria based on clinical studies, sample sizes for test and training sets, expert adjudication, or MRMC studies is not typically part of this type of submission.

The document explicitly states: "Clinical Tests: None required."

However, I can extract the general acceptance criteria and the type of studies conducted to support the device's substantial equivalence to the predicate device, the GE Vivid 3 Ultrasound System (K020789).

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical acceptance criteria or performance metrics from clinical studies are reported, the table will reflect the general safety and performance evaluation conducted for the 510(k) submission. The acceptance criteria here refer to compliance with safety standards and substantial equivalence to the predicate device.

Acceptance Criterion (General)	Reported Device Performance/Compliance
Device substantially equivalent to predicate device	The GE Vivid S5/S6 is of a comparable type and substantially equivalent to the currently marketed GE Vivid 3. It has the same intended uses as the predicate device. Its overall construction, materials, and performance are equivalent, although it is smaller and lighter.
Compliance with medical device safety standards	Evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. Found to conform with applicable medical device safety standards.
Compliance with quality systems	Design and development process conforms with 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. The document explicitly states "Clinical Tests: None required." The submission relies on non-clinical tests and comparison to a predicate device for substantial equivalence.
Data Provenance: Not applicable for clinical test data. Non-clinical evaluations were conducted by GE Healthcare and independent evaluation with ongoing factory surveillance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert-established ground truth was reported.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 2007 submission for an ultrasound system, not an AI-assisted diagnostic device. No MRMC comparative effectiveness study was performed or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is an ultrasound imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical ground truth. The "ground truth" for this submission is based on adherence to recognized medical device safety standards and the established performance and safety record of the predicate device (GE Vivid 3).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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

K071985

Special 510{k} Premarket Notification GE Vivid S5/S6 Diagnostic Ultrasound July 18, 2007

AUG 1 7 2007

Attachment B

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/5 description: The image shows the GE Healthcare logo and the address of the General Electric Company. The logo is a circular design with the letters "GE" inside. The address is P.O. Box 414, Milwaukee, WI 53201. The text is black and the background is white.

Section a):

1.	Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
	Contact Person:	Allen Schuh,Manager, Ultrasound Regulatory AffairsTelephone: 414-721-3992; Fax: 414-721-3899
	Date Prepared:	July 18, 2006
2.	Device Name:	GE Vivid S5/S6 Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO

Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX GE Vivid 3 Ultrasound System, K020789 currently in commercial distribution. 3. Marketed Device:

Device Description: The GE Vivid S5/S6 is a mobile ultrasound console having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular a and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Comparison with Predicate Device: The GE Vivid S5/S6 is of a comparable type and substantially equivalent to the currently marketed GE Vivid 3. Although it is somewhat smaller and lighter than Vivid 3. the overall construction, materials and performance as well as key safety and effectiveness features are equivalent. It has the same intended uses as the predicate device and includes transducers and features which are well established on other GE Vivid ultrasound systems.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE Vivid S5/S6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 2007

Mr. Allen Schuh Manager, Ultrasound Regulatory Affairs General Electric Co. GE Healthcarc 9900 Innovation Drive, Mail code-RP2138 WAUWATOSA WI 53226

Re: K071985

Trade Name: GE Vivid S5/S6 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: July 18, 2007 Received: July 19, 2007

Dear Mr. Schuh:

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 GE Vivid S5/S6 Diagnostic Ultrasound System, as described in your premarket notification:

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

	Transducer Model Number
4C-RS	3S-RS	9T-RS
8C-RS	5S-RS	P2D
E8C-RS	7S-RS	P6D
8L-RS	10S-RS
12L-RS	6T-RS

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

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,

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

"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 Lauren Hefner at (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)

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

Attachment E

Indications for Use Forms

Indications for use forms are provided for the overall system and for each Use/mode combinations designated as "P" were previously transducer. cleared with the unmodified Vivid 3. "E" represents use/mode combinations added to the Vivid 3 via Appendix E of the guidance. Transducers which have the miniature connector (with the "-RS" suffix), but with identical scan-heads and performance are considered to be the same as their full-size connector version.

E-1

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

GE Vivid S5/S6 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic	P	P	P	P	P	P	P	P	P	N
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	N
Abdominal (1)	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)[2]	P	P	P	P	P	P	P	P	P	N
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	N
Adult Cephalic	P	P	P	P	P	P	P	P	P	N
Cardiac[3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular	P	P	P	P	P	P	P	P	P	N
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	N
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	N
Other[4]	P	P	P	P	P	P	P	P	P	N
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	N
Transrectal	P	P	P	P	P	P	P	P	P	N
Transvaginal	P	P	P	P	P	P	P	P	P	N
Transurethral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

han

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

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

Special 510(k) Premarket Notification GE Vivid S5/S6 Diagnostic Ultrasound July 18, 2007

Diagnostic Ultrasound Indications for Use Form GE Vivid S5/S6 with 4C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N	N
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric	N	N	N		N		N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

IPI.EASE.DO NOT WRITE BELOW THIS LINE.-CONTINUE ON ANOTHER.PAGE.IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

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

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

GE Vivid S5/S6 with 8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N
Small Organ (specify)[2]	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

JWhang

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

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

GE Vivid S5/S6 with E8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse*	Other
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N	N
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N		N		N	N	N	N
Transvaginal	N	N	N		N		N	N	N	N
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

{5} Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). .

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[↑] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

Jhamp

(Division Sian-Off ision of Reproductive. Abdomin

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

GE Vivid S5/S6 with 8L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N
Small Organ (specify)[2]	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Iaparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

J. Whang

Division of Reproductive, Abdominal and Radiologic 510(k) Number

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

GE Vivid S5/6 with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse *	Other
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P		P	P	P	N
Small Organ[2]	P	P	P		P		P	P	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P		P	P	P	N
Musculo-skeletal Conventional	P	P	P		P		P	P	P	N
Musculo-skeletal Superficial	P	P	P		P		P	P	P	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative[5] (specify)	P	P	P		P		P	P	P	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV),

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

[•] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

Jwham

ion of Reproductive. Abdominal and 510(k) Nu

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

GE Vivid S5/S6 with 3S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	N
Abdominal[1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	N
Cardiac [3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Intracardiac

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Thhan

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

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

GE Vivid S5/S6 with 5S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	N
Abdominal[1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	N
Cardiac[3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
l anarosconic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

JWhang

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

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

GE Vivid S5/S6 with 7S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	N
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P	P	P	P	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Iatrogenic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

Thhay

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

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

Special 510(k) Premarket Notification GE Vivid S5/S6 Diagnostic Ultrasound July 18, 2007

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 10S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	N
Adult Cephalic	P	P	P	P	P	P	P	P	P	N
Cardiac[3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

[•] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

Thhm

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

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

GE Vivid S5/S6 with 6T-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	N
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

[•] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

(PLFASE DO NOT WRITE BELOW THIS I INE - CONTINUE ON ANOTHER PAGE IE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhan

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

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

GE Vivid S5/S6 with 9T-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	E	E	E	E	E	E	E	E	E	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	E	E	E	E	E	E	E	E	E	N
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[↑] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

(PLEASE DO NOT WRITE BEI OW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thhan

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

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

GE Vivid S5/S6 with P2D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

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

JWham

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

E-14

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

Special 510(k) Premarket Notification GE Vivid S5/S6 Diagnostic Ultrasound July 18, 2007

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with P6D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

[+] Coded Pulse includes B-flow, Coded Harmonics and Coded phase inversion.

(PLFASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE.JE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Uivision Sign-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number

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.