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

Device Description

The VividTM P3 is a high performance, mobile Color Doppler Ultrasound Imaging system. This system is designed for cardiovascular applications and including abdominal neonatal/pediatrics & intra-operative. It is integrated with keyboard control panel, LCD type video display and interchangeable electronic-array transducers.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the GE VIVID P3 ultrasound system. It outlines the device's technical specifications and intended uses, primarily to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the VIVID P3. Instead, it focuses on demonstrating that the VIVID P3 is substantially equivalent to its predicate devices by sharing the same fundamental scientific technology and conforming to applicable medical device safety standards. The "performance" reported is primarily the list of clinical applications and operating modes for which the device and its various transducers ("4C", "E8Cs", "8L", "8C", "5Cs", "3S", "11L", "T739", "6S") are intended and "previously cleared by FDA".

The device performance is implied through compliance with and application of:

Acoustic output evaluation (Summary of Non-Clinical Tests)
Biocompatibility evaluation (Summary of Non-Clinical Tests)
Cleaning and disinfection effectiveness evaluation (Summary of Non-Clinical Tests)
Thermal, electrical, electromagnetic, and mechanical safety standards (Summary of Non-Clinical Tests)
Voluntary standards as detailed in Sections 9, 11, 15, and 17 of the premarket submission (Summary of Non-Clinical Tests) - These specific standards are not detailed in the provided excerpt.
Application of quality assurance measures: Risk Management, Requirement Reviews, Design reviews, Unit level testing (Module Verification), Integration Testing (System level verification), Final acceptance testing (Validation), Performance testing (Verification), and Safety testing (Verification).

2. Sample Sizes Used for the Test Set and Data Provenance:

The document explicitly states: "The subject of this premarket submission, VIVID P3, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set or associated sample size for clinical performance evaluation mentioned. The provenance of any data used for non-clinical tests (acoustic output, biocompatibility, etc.) is not specified, nor is whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Since no clinical studies were required or performed to establish substantial equivalence based on clinical performance, there is no mention of experts establishing ground truth for a test set in clinical scenarios.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies with a test set requiring expert adjudication are mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not conducted or mentioned. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The VIVID P3 is an ultrasound imaging system with various transducers, not a standalone algorithm. Its performance is demonstrated through its hardware and software capabilities as a whole system, benchmarked against predicate devices in terms of safety and technical specifications, not typically through standalone algorithmic metrics.

7. Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" for the device's acceptability is its substantial equivalence to existing, legally marketed predicate devices (GE Logiq e/i & Vivid e - K072797, GE Logiq P5/A5 K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079) and its conformity to recognized medical device safety standards. This is established through non-clinical testing and internal quality assurance measures rather than clinical outcome data or pathology. The "ground truth" for its intended uses is that these uses were "previously cleared by FDA" for the predicate devices or previous iterations of GE's ultrasound systems.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device submission based on substantial equivalence, not an AI or machine learning model that would typically involve training sets for performance evaluation.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned in this context.

Summary

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

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are small, decorative flourishes or swirls around the letters within the circle.

OCT 1 2010

GE Healthcare 510(k) Premarket Notification Submission

K102104

Section 5: 510(k) Summary

VIVID P3

.『

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

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is presented in black against a white background, giving it a high contrast and making it easily recognizable.

OCT 1 2010

K102104

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

Date:	16-July-2010
Submitter:	WIPRO GE HEALTHCARE PRIVATE LTD.No. 4, Kadugodi Industrial AreaBangalore, Karnataka - 560067. India.
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE Healthcare9900 Innovation Dr.Wauwatosa, WI 53226Telephone: 414-721-4214Fax: 414-918-8275
Secondary Contact Person:	Gurunathan MRegulatory Affairs Leader- ProductWipro GE Healthcare Private LtdTelephone: 91-80-4088-2108Fax: 91-80-2841-1645
Device:	VIVID P3
Classification Names:Product Code:	Diagnostic Ultrasound Imaging SystemUltrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging System and DiagnosticUltrasonic Transducer
	Primary - IYN - 21CFR 892.1550; IYO - 21CFR 892.1560 &Secondary - ITX – 21CFR 892.1570
Predicate Device(s):	GE Logiq e/i & Vivid e - K072797, GE Logiq P5/A5 K060993,GE Logiq P6 K073297, GE Vivid S5/S6 K092079
Device Description:	The VividTM P3 is a high performance, mobile Color DopplerUltrasound Imaging system. This system is designed forcardiovascular applications and including abdominalneonatal/pediatrics & intra-operative. It is integrated withkeyboard control panel, LCD type video display andinterchangeable electronic-array transducers.

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

Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are in black, creating a high-contrast design. The logo is simple, recognizable, and represents the General Electric company.

GE Healthcare 510(k) Premarket Notification Submission

The device is intended for use by a qualified physician for Intended Use: ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.
- The VIVID P3 employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: The device has been evaluated for acoustic output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The VIVID P3 and its applications comply with voluntary standards as detailed in Section 9, 11, 15 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Management
Requirement Reviews .
. Design reviews
Unit level testing (Module Verification) .
Integration Testing (System level verification) .
. Final acceptance testing (Validation)
Performance testing (Verification) .
Safety testing (Verification) .

Summary of Clinical Tests:

The subject of this premarket submission, VIVID P3, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the VIVID P3 to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

WIPRO GE Healthcare Private, Ltd. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226

DCT ] 2010

Re: K102104

Trade/Device Name: VIVID P3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 3, 2010 Received: September 8, 2010

Dear Mr. Behn:

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 VIVID P3 Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C
E8Cs
8L
8C
5Cs
3S

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

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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Marl O'Keefer for

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, creating a unique and recognizable design. The logo is in black and white.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: VIVID P3

Indications for Use:

The device is intended for use by a qualified physician for ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular, Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculoskeletal Conventional, Urology (including prostate), Transrectal and Transvaginal.

Prescription Use: Yes AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: No (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ikel D. Othen for David G. Brown
(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K102104

Page 1 of 1

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

GE VIVID P3 Ultrasound System

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse	[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P	[5,6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6]
Small Organ [2]	P	P	P	P	P	P	P	P	P	P	[5,6]

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	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other [4]	P	P	P	P	P	P	P	P	P	P	[5,6]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P	[5,6]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P	[5,6]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ed Dóthm G. David G. Brown
(Division Sign-Off)

Division of Raciological Device Office of In Vitro Diagnostic Device Evaluation and Sarety

510K. K192104

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

GE VIVID P3 with 4C 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		[5,6]
Abdominal [1]	P	P	P		P	P	P	P	P		[5,6]
Pediatric	P	P	P		P	P	P	P	P		[5,6]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P		P	P	P	P	P		[5,6]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; Previously cleared on GE LOGIQ P5/A5 K060993

Notes: [1] Abdominal includes renal, GYN/Pelvic ,

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

[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/TH1, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Zahad D'O'Hara for David G. Brown
(Division Sign-Off)

Division of Radiological Devices
fice of In Vitro Diagnostic Device Evaluation and Saiety

610K K102104

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

GE VIVID P3 with E8Cs 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		[5,6]
Abdominal [1]	P	P	P		P		P	P	P		[5,6]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P		P		P	P	P		[5,6]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P	P		[5,6]
Transvaginal	P	P	P		P		P	P	P		[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (Previously cleared on GE LOGIQ P5/A5 K060993);

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Dission Sign-

Division of Radiological Devices Iffice of in vitre. Diagnostic Device Evaluation and Safety

510K K102104

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

GE VIVID P3 with 8L 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	P	P	P		P	P	P	P	P		[5,6]
Small Organ [2]	P	P	P		P	P	P	P	P		[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P		[5,6]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: {1} Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Zackary D. Knauss for David G. Brown
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102164

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

GE VIVID P3 with 8C 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		[5]
Pediatric	P	P	P		P	P	P	P	P		[5]
Small Organ [2]	P	P	P		P	P	P	P	P		[5]
Neonatal Cephalic	P	P	P		P	P	P	P	P		[5]
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PD1, B/CF/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

James L. D'Olive
(Division Sign-Off) Gia David G. Brown

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102104

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

GE VIVID P3 with 5Cs 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		[5,6]
Abdominal [1]	P	P	P		P	P	P	P	P		[5,6]
Pediatric	P	P	P		P	P	P	P	P		[5,6]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P		P	P	P	P	P		[5,6]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (Previously Cleared on GE LOGIQ P5/A5 K060993);

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Frankl D.O'K for David G. Brown
(Division Sign-Off)

Division of Radiologica Office of In Vitro Diagnostic on and Safety

510K K102104

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

GE VIVID P3 with 3S Transducer

Intended Use: Diagnostic uttrasound 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	НапполісImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal 1)	P	P	P	P	P	P	P	P	P		(5,6)
Pediatric	P	P	P	P	P	P	P	P	P		(5,6)
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P		િર'ણ
Cardiac [3]	P	P	P	P	P	P	P	b	P		(5, 6)
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (4)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

{2} Small organ includes breast, testes and thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI; B/CF/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

PRESCRIPTION USER (PER 21 CFR 801.109) .

Indal D. O'Kee for David G. Brown
(Division Sign-Off)

and Safety

Division of Radiolo Office of In Vi

510K

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

GE VIVID P3 with 11L 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	P	P	P		P	P	P	P	P		[5,6]
Small Organ [2]	P	P	P		P	P	P	P	P		[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P		[5,6]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P		[5,6]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (Previously Cleared on GE LOGIQ P5/A5 K060993);

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PDI, B/CF/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

PRESCRIPTION USER (PER 21 CFR 801.109)

Nuhal DSR for David G. Brow h
(Division Sign-Off)

Office of In Vitro Diagnostic Device Eva ation and Safety

510K

K102164

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

GE VIVID P3 with T739 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	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]
Pediatric
Small Organ [2]	P	P	P	P	P	P	P	P	[5]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P	P	P	P	P	P	[5]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	[5]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/PD1, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

PRESCRIPTION USER (PER 21 CFR 801.109) ·

Division of Radiok

K102104

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

GE VIVID P3 with 6S 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		[5]
Pediatric	P	P	P	P	P	P	P	P	P		[5]
Small Organ [2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P		[5]
Adult Cephalic	P	P	P	P	P	P	P	P	P		[5]
Cardiac [3]	P	P	P	P	P	P	P	P	P		[5]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] 3D Imaging Mode

[6] Needle guidance Imaging

[*] Combined modes are B/M, B/PWD, B/CF/PWD, B/CF/CWD, B/CWD, B/CWD, B/THI, and B/CMM

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sior

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K 5102104

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.