The Vivid T8 is a multipurpose cardiovascular ultrasound system intended for diagnostic ultrasound imaging and fluid flow analysis. The system supports the following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular. Adult Cephalic. Neonatal Cephalic. Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.

Device Description

The Vivid T8 is the full featured cardiovascular diagnostic ultrasound system designed for cardiac and shared service imaging which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel

AI/ML Overview

This is a premarket notification for the GE Vivid T8 ultrasound system. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of the information that is present in relation to your request, and what is not:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria for diagnostic performance or specific device performance metrics in relation to clinical efficacy.
The tables provided (pages 5-16) describe "Indications for Use" for different transducers with various clinical applications and modes of operation. These tables indicate whether an indication is "new" (N) or "previously cleared" (P, P1, P2) with predicate devices. This represents the scope of intended use rather than performance criteria.
The "Summary of Non-Clinical Tests" (page 19-20) lists compliance with various medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, ISO14971, NEMA DICOM). These are safety and engineering standards, not diagnostic performance acceptance criteria.

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

The document explicitly states on page 20, "The subject of this premarket submission, Vivid T8, did not require clinical studies to support substantial equivalence."
Therefore, there is no information on a test set, sample size, or data provenance related to clinical diagnostic performance.

3. 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)

As clinical studies were not required, there is no information on experts, ground truth establishment, or their qualifications.

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

As clinical studies were not required, there is no information on an adjudication method.

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

No clinical studies were performed. The document mentions "Scan Coach feature" and "Smart Start feature with battery" as additions, stating they are "equivalent to that cleared in the LOGIQ F Series (K133034)" and "equivalent to that cleared in Vivid S5/S6 (K121063)" respectively (page 18). These are features, possibly with AI components, but no MRMC study or effect size of AI assistance is discussed or presented.

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

No clinical studies or standalone algorithm performance evaluations are discussed.

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

No ground truth for diagnostic performance is discussed as clinical studies were not performed.

8. The sample size for the training set

No information about a training set for an AI/algorithm is provided.

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

No information about ground truth establishment for a training set is provided.

In summary, this FDA 510(k) clearance document for the GE Vivid T8 ultrasound system does not contain the detailed information requested regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, imaging capabilities, technological characteristics, and compliance with safety standards, without requiring new clinical performance studies.

Summary

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

December 10, 2016

GE Medical Systems Ultrasound and Primary Care Diagnotics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K160078 Trade/Device Name: Vivid T8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 12, 2016 Received: January 14, 2016

Dear Ms. Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oels

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if kno

K16007
Device Name
Vivid T8

Indications for Use (Describe)

The Vivid T8 is a multipupose cardiovascular ultrasound system designed for cardiac and shared service imaging. The system supports the following applications: Fetal OB, Abdominal, Pediac, Perpheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculoskeletal Conventional, Transcranial, Transvaginal and Transesophageal.

Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740 EF

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid T8. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

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Diagnostic Ultrasound Indications for Use Form GE Vivid T8 Diagnostic Ultrasound System

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
	B	M	Doppler Modes						Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			PW	CW	Color	ColorM	Power	Modes *	Imaging	Pulse**
Ophthalmic
Fetal/OB	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	N	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
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial	P	P	P	P	P	P	P	P	P	P	P
Transorbital
Transesophageal	P	P	P	P	P	P		P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P	P
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage	N	N	N	N	N	N	N	N	N	N	N	4

N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

*] Combined modes are B/M, B/PWD, B/Color/PWD

[**] Coded Pulse is for digitally encoded harmonics.

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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GE Healthcare 510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Vivid T8 with 4C-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes	CombinedModes *	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P
Pediatric	P1	P1	P1	P1	P1	P1	P1
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage	P2	P2	P2	P2	P2	P2	4

N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
**] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Diagnostic Ultrasound Indications for Use Form GE Vivid T8 with 8C-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
					Doppler Modes
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	Power	CombinedModes*	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB
Abdominal [1]
Pediatric	P	P	P	P	P		P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P		P	P	P	P
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P	P	P		P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage

N = new indication; P = previously cleared by FDA K141067; P1= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

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

[**] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with E8C-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
		M			Doppler Modes							Other
Anatomy/Region of Interest	B		PW	CW	Color	Color M	Power	CombinedModes *	HarmonicImaging	CodedPulse**
Ophthalmic
Fetal/OB	P	P	P		P		P	P	P	P
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal	P	P	P		P		P	P	P	P
Transvaginal	P	P	P		P		P	P	P	P
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage	P²	P²	P²		P²		P²	P²	P²	P²	4

N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame in the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 3Sc-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes				CombinedModes*	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB
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]
Neonatal Cephalic
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
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial	P	P	P	P	P	P	P	P	P	P	P
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	4

N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement;
[*] Combined modes are B/M, B/PWD, B/Color/PWD
** ] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the General Electric brand.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 6S-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
						Doppler Modes	Combined Harmonic	Coded
Anatomy/Region of Interest	B	M	PWCW Color		ColorM	Power	Modes*	Imaging	Pulse**	Other
Ophthalmic
Fetal/OB	P	P	P	P	P	P		P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P		P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiacl3]	P	P	P	P	P	P		P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage

N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 12S-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PW	CW	Doppler ModesColor	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB
Abdominal[1]	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	N
Pediatric	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	N
Small Organ (specify)[2]
Neonatal Cephalic	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	N
Adult Cephalic
Cardiac[3]	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	N
Peripheral Vascular	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage

N = new indication; P = previously cleared by FDA K141067; P1= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
**] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 6Tc-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes					CombinedModes*	HarmonicImaging	CodedPulse**	Other
			PW	CW	Color	ColorM	Power
Ophthalmic
Fetal/OB
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P		P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal	P	P	P	P	P	P		P	P	P
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage

N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

| Combined modes are B/M, B/PWD, B/Color/PWD
] Coded Pulse is for digitally encoded harmonics

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with P2D Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
		M			Doppler Modes
Anatomy/Region of Interest	B		PW	CW	Color	ColorM	Power	Combined Harmonic*	Imaging	Coded Pulse**	Other
Ophthalmic
Fetal/OB
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidanceof
Tissue Biopsy / Fluid Drainage

N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] 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 In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular shape. The logo is colored in blue, with the letters and the surrounding circle being the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with L6-12-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
					Doppler Modes					CombinedModes *	HarmonicImaging	CodedPulse**	Other
Anatomy/Region of Interest	B	M	PW	CW	Color	ColorM	Power
Ophthalmic
Fetal/OB
Abdominal[1]	P	P	P		P		P	P	P	P	P
Pediatric	P	P	P		P		P	P	P	P	P
Small Organ (specify)[2]	P	P	P		P		P	P	P	P	P
Neonatal Cephalic	P	P	P		P		P	P	P	P	P
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P		P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P	P	P
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidance
Tissue Biopsy / Fluid Drainage	P2		P2		P2		P2	P2	P2	P2		4

N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] 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 In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 9L-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
			Doppler Modes
Anatomy/Region of Interest	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB
Abdominal[1]	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Pediatric	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Small Organ (specify)[2]	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Musculo-skeletal Conventional	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Musculo-skeletal Superficial	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹	p¹
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidanceof
Tissue Biopsy / Fluid Drainage	N	N	N	N	N	N	N	N	N	N	4

N = new indication; P = previously cleared by FDA K141067; P= previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] 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 In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular shape. The logo is colored in blue, with the letters and the surrounding circle being the same shade of blue.

Diagnostic Ultrasound Indications for Use Form

GE Vivid T8 with 12L-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	Doppler Modes
			PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse**	Other
Ophthalmic
Fetal/OB
Abdominal[1]	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Pediatric	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Small Organ (specify)[2]	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Musculo-skeletal Conventional	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Musculo-skeletal Superficial	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹	P¹
Thoracic/Pleural (specify)
Other (specify)
Exam Type, Means of Access
Transcranial
Transorbital
Transesophageal
Transrectal
Transvaginal
Intraoperative (specify)
Intraoperative Neurological
Laparoscopic
Interventional Guidanceof
Tissue Biopsy / Fluid Drainage	N	N	N	N	N	N	N	N	N	N	4

N = new indication; P = previously cleared by FDA K141067; P = previously cleared by FDA K121063;

P2 = previously cleared by FDA K133034

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, and thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement;

[*] Combined modes are B/M, B/PWD, B/Color/PWD
[**] 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 In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/17/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are swirling designs around the letters. The logo is simple and recognizable.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	January 12, 2016
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120F:(414)918-8275
Secondary Contact Person:	Nick XuRegulatory AffairsGE Medical Systems (China) Co, Ltd.T: +86 510 8527 8639F: +86 510 8522 7347
Device:Trade Name:	Vivid T8
Common/Usual Name:	Ultrasound System
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Predicate Device(s):	K141067 GE Vivid T8 / Vivid T8 ProK121063 GE Vivid S5 / Vivid S6K133034 GE LOGIQ F Series
Device Description:	The Vivid T8 is the full featured cardiovascular diagnosticultrasound system designed for cardiac and shared serviceimaging which consists of a mobile console that provides digitalacquisition, processing and display capability. The user interfaceincludes a computer keyboard, color LCD image display andtouch panel
Intended Use:	The Vivid T8 is a multipurpose cardiovascular ultrasound systemintended for diagnostic ultrasound imaging and fluid flowanalysis. The system supports the following applications:Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac,Peripheral Vascular. Adult Cephalic. Neonatal Cephalic.

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Image /page/18/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 frame, and there are decorative swirls or flourishes surrounding the circle. The logo is presented in a blue color.

Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.

Technology: The Vivid T8 employs the same fundamental scientific technology as its predicate devices.

Comparison to Predicate Devices

Determination of Substantial Equivalence:

The Vivid T8 system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The Vivid T8 and predicate Vivid T8 (K141067 systems ● have the same clinical indications. The IFU tables are being updated to clarify biopsy/needle guidance on the 4C-RS, E8C-RS, L6-12-RS and 3Sc-RS which was cleared per predicate LOGIQ F (K133034) and is added with 9L-RS and 12L-RS that are added with this submission.
The Vivid T8 and predicate Vivid T8 systems have the same imaging modes.
The Vivid T8 and predicate Vivid T8 systems transducers are identical except for the 12S-RS, 9L-RS and 12L-RS which are the same transducers cleared in predicate Vivid S5/S6 (K121063).
The systems are manufactured with materials which have ● been evaluated and found to be safe for the intended use of the device.
The systems have acoustic power levels which are below the applicable FDA limits.
The Vivid T8 and predicate Vivid T8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
. The Vivid T8 and predicate Vivid T8 systems have been designed in compliance with approved electrical and physical safety standards.
The Scan Coach feature is being added and is equivalent to that cleared in the LOGIQ F Series (K133034).
Smart Start feature with battery is being added and is equivalent to that cleared in Vivid S5/S6 (K121063).
o The embedded operating system has been changed from Window XP to Windows 7.

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Image /page/19/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. There are decorative swirls around the letters and the outer edge of the circle. The logo is simple and recognizable, representing the company's brand.

An update has been made to the hardware flex arm. ●

Summary of Non-Clinical Tests:

has been evaluated for acoustic Vivid T8 output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Vivid T8 complies with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety
IEC60601-1-2, Medical Electrical Equipment -● Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
ISO14971, Application of risk management to medical ● devices
NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures are applied to the development of the system:

Risk Analysis ●
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification) ●

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Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.

Safety testing (Verification) ●
Simulated use testing (Validation) o

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid T8, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Vivid T8 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.