Predicate Devices

K141067 GE Vivid T8 / Vivid T8 Pro, K121063 GE Vivid S5 / Vivid S6, K133034 GE LOGIQ F Series

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with digital processing capabilities but does not mention AI, ML, or any related technologies.

Therapeutic

No.
The device is intended for diagnostic imaging and fluid flow analysis, not for treating or preventing disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging and fluid flow analysis," and the "Device Description" also refers to it as a "cardiovascular diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile console" with a "computer keyboard, color LCD image display and touch panel," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vivid T8 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The description of the Vivid T8 clearly states it is an ultrasound system used for diagnostic imaging and fluid flow analysis directly on the patient's body.
The intended use and anatomical sites listed are all related to imaging internal structures of the body. There is no mention of analyzing blood, tissue samples, or other bodily fluids in vitro (outside the body).

Therefore, the Vivid T8 is a medical imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest:
Fetal/OB, Abdominal, Pediatric, Small Organ (breast, testes, and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult and Pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transesophageal, Transrectal, Transvaginal, Tissue Biopsy / Fluid Drainage (Includes image guidance for freehand needle placement).

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

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/OB, Abdominal (includes GYN and Urological), Pediatric, Small Organ (includes breast, testes, and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transesophageal, Transrectal, Transvaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141067 GE Vivid T8 / Vivid T8 Pro, K121063 GE Vivid S5 / Vivid S6, K133034 GE LOGIQ F Series

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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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.

1

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	Color
M	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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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	Combined
Modes *	Harmonic
Imaging	Coded
Pulse**	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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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	Color
M	Power	Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	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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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	Combined
Modes *	Harmonic
Imaging	Coded
Pulse**
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				Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	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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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	PW
CW Color		Color
M	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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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 Modes
Color	Color M	Power	Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	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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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				Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	Other
			PW	CW	Color	Color
M	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	Color
M	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					Combined
Modes *	Harmonic
Imaging	Coded
Pulse**	Other
Anatomy/Region of Interest	B	M	PW	CW	Color	Color
M	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	Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	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	Combined
Modes*	Harmonic
Imaging	Coded
Pulse**	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 Diagnostics
9900 Innovation Drive
Wauwatosa, WI 53226
Primary Contact Person:	Tracey Ortiz
Regulatory Affairs Director
GE Healthcare
T:(262)676-6120
F:(414)918-8275
Secondary Contact Person:	Nick Xu
Regulatory Affairs
GE Medical Systems (China) Co, Ltd.
T: +86 510 8527 8639
F: +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 90
IYN 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 Pro
K121063 GE Vivid S5 / Vivid S6
K133034 GE LOGIQ F Series
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
Intended Use:	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.

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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).