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

Device Description

The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.

AI/ML Overview

The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.

Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.

Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.

The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.

Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by 510(k) for Substantial Equivalence)	Reported Device Performance (as per submission)
Safety: Device must conform to applicable medical device safety standards (e.g., acoustic output, biocompatibility, electrical, thermal, mechanical safety, cleaning/disinfection effectiveness).	"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." (Attachment B, Section b) 1.)
Effectiveness: Similar intended uses and operating modes to the predicate device, or demonstrated equivalence for new indications based on prior clearance of similar technology.	"The modified GE Vivid S5/S6 is of a comparable type and substantially equivalent to the current GE Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device and additional software that are similar to other cleared GE Ultrasound systems." (Attachment B, Section 6.)
Expanded Indications: New transducers and their associated clinical applications (e.g., Fetal/Obstetrics, Abdominal, Pediatric, Cardiac, Peripheral Vascular, Small Organ, Musculo-skeletal, Transesophageal, Transvaginal, Intraoperative) must be supported by previous clearances of similar technology.	For each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 12L-RS, 7S-RS, 10S-RS, M4S-RS, 6Tc-RS, i12L-RS, 6S-RS, 9L-RS), the Indications for Use forms clearly mark "N" for new indications, accompanied by a note stating that the transducer or application was "previously cleared" on another specified GE ultrasound system (e.g., Vivid 7 BT05 (K051449), GE LOGIQ Book Ultrasound (K032477), Vivid i/q (K082374), LOGIQ 9 (K011188), Vivid E9 (K081921), LOGIQ P5 (K060993)). "P" indicates indications previously cleared on the predicate device (K071985).
Compliance: Design and development process conforms to 21 CFR 820 and ISO13485 quality systems.	"The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems." (Attachment B, Section b) 3.)

The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.

Missing Information (as per the document):

Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
How the ground truth for the training set was established: Not applicable.

Summary

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K092079

Attachment B Summary of Safety and Effectiveness

GE Healthcare

General Electric Company 3000 N. Grandview Blvd., Waukesha, WI 53188

1. Submitter:	GE Healthcare3000 N. Grandview Blvd., W450Waukesha, WI 53188USA
Contact Person:	James T. Turner, MS, RACUSA Premarket RA LeaderTelephone: 262-544-3359; Fax: 414-908-9225
Date Prepared:	June, XX 2009
2. Device Name:	GE Vivid S5 and Vivid S6 Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX

. 3. Marketed Device: GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985 currently in commercial distribution.
Device Description: The GE Vivid S6 are mobile ultrasound consoles having a wide 4. assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5. Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
1. Comparison with Predicate Device: The modified GE Vivid S5/S6 is of a comparable type and substantially equivalent to the current GE Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device and additional software that are similar to other cleared GE Ultrasound systems.
Section b): 7.
1. 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 tound to conform with applicable medical device safety standards.
1. Clinical Tests: None required.
1. 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, 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.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

GE Medical Systems Israel, Ultrasound, Ltd. % Mr. James T. Turner USA Premarket RA Leader GE Healthcare, QARA Regions - Americas 3000 N. Grandview Blvd., W450 WAUKESHA WI 53188

AUG 0 6 2009

Re: K092079

Trade/Device Name: GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: July 7, 2009 Received: July 9, 2009

Dear Mr. Turner:

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:

Transducer Model Number

4C-RS
8C-RS
E8C-RS
8L-RS
12L-RS
7S-RS

10S-RS
M4S-RS
6Tc-RS
i12L-RS
6S-RS
9L-RS

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

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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Robert Ochs at (301) 796-6661.

Sincerely yours,

Heike Lemmer

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 Diagnostic Ultrasound System

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

ClinicalApplicationAnatomy/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	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Transurethral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intravascular

N = new indication; P = prevlously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

[1] Abdominal includes GYN/Pelvic and Renal. Notes:

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

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

[↑] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109)

Heleen

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

510(k) Number

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

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:

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

N = new indication - Peripheral Vascular application previously cleared on Vivid 7 BT05 (K051449);

P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

[4] Other use includes Urology.

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

[+] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

(Division Sign Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number. K092079 F-3

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 8C-RS Transducer

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

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

N = new indication - cardiac indication previously cleared on GE LOGIQ Book Ultrasound (K032477);

P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

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

[3] Cardiac is Adult and Pediatric.

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

[+] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 807.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K092079
F-4

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

Diagnostic Ultrasound Indications for Use Form

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

N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

[1] Abdominal Includes GYN/Pelvic and Renal. Notes:

[4] Other use includes Urology.

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

[+] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per21 CFR 801.109)

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

and Radiological Device

510(k) Number.

E-S

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 8L-RS Transducer

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

	Mode of Operation
ClinicalApplicationAnatomy/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	N	P	P	P	P
Pediatric	P	P	P	P	P	N	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	N	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	N	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	N	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	N	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

[1] Abdominal Includes GYN/Pelvic and Renal. Notes:

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

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

[↑] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109)

Hul Reen

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

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

Diagnostic Ultrasound Indications for Use Form

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

N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

Notes:

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

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

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

{↓] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription User (Per 21 CFR 801:109)

Nul Reen

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

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

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
ClinicalApplicationAnatomy/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	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication - previously cleared by FDA on Vivid i/q (K082374);

P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

[1] Abdominal includes GYN/Pelvic and Renal. Notes:

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

[+] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 OFR 801.109)

Neel Keem

(Division Sign-Off) (Division Sigh-Uff)
Division of Reproductive, Abdominal, Division of the first

510(k) Number.

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

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
ClinicalApplicationAnatomy/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	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication -previously cleared by FDA on Vivid I/q (K082374);

P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

[3] Cardiac is Adult and Pediatric.

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

[+] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109)

Description User (For P-21 or P-21T/P-21TS)

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

Radiological Devices
510(k) Number K092079

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with M4S-RS Transducer

Intended Use: Ultrasound imaging, measurement and 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	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication, (Transducer previously cleared on Vivid 7 BT05 (K051449)); P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

[3] Cardiac is Adult and Pediatric.

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

[+] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

Herbeem

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

510(k) Number.

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 6Tc-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	Combined Modes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication (Transducer previously cleared on Vivid Vq K082374); P = previously cleared by FDA;

E = added under Appendix E

Notes:

[3] Cardiac is Adult and Pediatric.

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

[♦] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109)

Signature

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

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with i12L-RS Transducer

Intended Use: Ultrasound imaging, measurement and 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]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)[2]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	N	N	N	N	N	N	N	N	N	N
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication (Transducer previously cleared on LOGIQ 9 (K011188)); P = previously cleared by FDA;

E = added under Appendix E

510(k) Number

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

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

[3] Cardiac is Adult and Pediatric.

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

f*1 Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[+] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

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

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 6S-RS Transducer

Intended Use: Ultrasound imaging, measurement and 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	N	N
Abdominal(1)	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac(3)	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication (Transducer previously cleared on Vivid E9 (K081921); P = previously cleared by FDA;

E = added under Appendix E

[1] Abdominal includes GYN/Pelvic and Renal. Notes:

[3] Cardiac is Adult and Pediatric.

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

[+] Coded Pulse is for digitally encoded harmonics.

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

Prescription User (Per 21 CFR 801.109)

Helbaum

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

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 9L-RS Transducer

Intended Use: Ultrasound imaging, measurement and 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]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ[2]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletalConventional	N	N	N	N	N	N	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N	N	N	N	N	N	N
Other (specify)!
Exam Type, Means ofAccess
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
IntraoperativeNeurological
Intravascular
Laparosconic

N = new indication (Transducer previously cleared on LOGIQ P5 (K060993);

P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes GYN/Pelvic and Renal Notes:

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

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

[+] Coded Pulse is for digitally encoded harmonics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CERT 801-109)

les deen

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

*10(k) Number

E-14

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.