Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, deep learning, or any related terms, nor does it describe features or functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis powered by learned algorithms).

Therapeutic

No
The device is described as a "general-purpose ultrasound system" for "ultrasound imaging and analysis," and "a general-purpose ultrasound system, specialized for use in cardiac imaging," indicating its diagnostic purpose rather than therapeutic.

Diagnostic

Yes
The "Device Description" explicitly states, "Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a mobile console, keyboard control panel, touch panel, video display, and transducers, indicating it is a physical ultrasound system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Vivid E80 / Vivid E90 / Vivid E95 is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Intended Use: The intended use clearly describes imaging and analysis of various anatomical sites within the body. It does not mention testing of samples taken from the body.

Therefore, the Vivid E80 / Vivid E90 / Vivid E95 is a medical device used for diagnostic imaging in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

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

IYN, IYO, ITX

Device Description

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, OLED color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

Mentions image processing

Yes, the device is a diagnostic ultrasound imaging system and provides "real-time 3D and 4D acquisition."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate)

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Qualified physician

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 E80 / Vivid E90 / Vivid E95, 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.

Vivid E80, Vivid E90, Vivid E95 (K150087), LOGIQ E9 (K163077), Vivid S60, Vivid S70 (K142323), TomTec Arena TTA2 (K150122)

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

0

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

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

June 12, 2017

Re: K170823

Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 15, 2017 Received: May 16, 2017

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-

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1

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.

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/ResourcesforYou/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,

Michael D. O'Hara

For

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

Enclosure

2

Indications for Use

510(k) Number (if known) K170823

Device Name Vivid E80 Vivid E90 Vivid E95

Indications for Use (Describe)

Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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."

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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 E80, Vivid E90 and Vivid E95. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Vivid E80 / Vivid E90 / Vivid E95 Transducer: C3-10-D Transducer: 12S-D Transducer: 4V-D Transducer: iC5-9-D Transducer: 8C Transducer: C2-9-D Transducer: 9L-D Transducer: 11L-D Transducer: M5Sc-D Transducer: 6S-D Transducer: C1-6-D Transducer: L8-18i-D Transducer: 6VT-D Transducer: 6Tc Transducer: 6Tc-RS Transducer: 9T Transducer: 9T-RS Transducer: P2D Transducer: P6D

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Image /page/4/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 circular frame. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form Vivid E80 / Vivid E90 / Vivid E95 Ultrasound System

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[6,8,9]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,6,8,9,10]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6,8,9]
Small Organ	P	P	P	P	P	P	P	P	P	P	[2,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[8,9]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[6,9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,6,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[8]
Other	P	P	P	P	P	P	P	P	P	P	[4,6,8,9]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	[6,9]
Transrectal	P	P	P	P	P	P	P	P		P	[8]
Transvaginal	P	P	P	P	P	P	P	P		P	[8]
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8,9]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

[2] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [3]
Other use includes Urology/Prostate [4]
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular border. The color of the logo and the border is a light blue.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C3-10-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	N	N	N	N	N	N	N	N	N	N	[8]
Pediatric	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[8]
Small Organ
Neonatal Cephalic	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[8]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	[8]
Musculo-skeletal Superficial	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[7,8]
Vascular Access (IV, PICC)	P1	P1	P1	P1	P1	N	P1	P1	P1	P1	[8]

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

Small organ includes breast, testes, thyroid. [2]
Cardiac is Adult and Pediatric. [3]
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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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Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 12S-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]

[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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/7/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 blue circle. The circle has decorative flourishes at the top, bottom, left, and right, resembling stylized petals or leaves. The logo is simple, recognizable, and associated with the multinational conglomerate corporation.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4V-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[6,9]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6,9]
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[6,9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,6,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]

[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

8

Image /page/8/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 blue circle. The letters are also blue, matching the color of the circle that surrounds them.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with iC5-9-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[8]
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P		P	[8]
Transvaginal	P	P	P	P	P	P	P	P		P	[8]
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P		P	[7,8]
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P		P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode [6]
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

9

Image /page/9/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 blue circle. There are four small, stylized teardrop shapes evenly spaced around the outside of the circle, adding a decorative element to the design.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 8C Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	P	P	N	P	[1,8,10]
Pediatric	P	P	P	P	P	P	P	P	N	P	[8]
Small Organ (specify)	P	P	P	P	P	P	P	P	N	P	[8]
Neonatal Cephalic	P	P	P	P	P	P	P	P	N	P	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	N	P	[8]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	[8]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	N	P	[8]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode [6]
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

10

Image /page/10/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 blue circle. There are four small, stylized teardrop shapes evenly spaced around the outer edge of the circle, adding a decorative element to the design.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C2-9-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[8]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,8,10]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode ાંઠા
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

11

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

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9L-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P1	b1	P1	bl	P1	P1	P1	P1	P1	[8]
Pediatric	P	P	P	P	P	P	P	P	P	[8]
Small Organ	P	P	P	P	P	P	P	P	P	[2,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

Small organ includes breast, testes, thyroid. [2]
Cardiac is Adult and Pediatric. [3]
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

12

Image /page/12/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 border. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 11L-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P	P	P	P	P	P	P	[8]
Small Organ	P	P	P	P	P	P	P	P	P	[2,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

Small organ includes breast, testes, thyroid. [2]
Cardiac is Adult and Pediatric. [3]
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with M5Sc-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[9]
Abdominal	P	P	P	P	P	P	P	P	P	P	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[9]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

Small organ includes breast, testes, thyroid. [2]
Cardiac is Adult and Pediatric. [3]
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The color of the logo is blue, and the background is white.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6S-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[9]
Abdominal	P	P	P	P	P	P	P	P	P	P	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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

Small organ includes breast, testes, thyroid. [2]
Cardiac is Adult and Pediatric. [3]
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is simple, yet iconic, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C1-6-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[8]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,8]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV PICC)

P = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

16

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, and the circle has decorative flourishes around its perimeter. The logo is simple and recognizable, representing the General Electric brand.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with L8-18i-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ	P	P	P	P	P	P	P	P	P	P	[2,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

17

Image /page/17/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 blue circle. The letters are also blue, matching the color of the circle that surrounds them.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6VT-D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]

Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[6,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	[6,9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode [6]
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

18

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6Tc/6Tc-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Modes	Combined Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	[a]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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) Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
(6) 3D/4D Imaging mode
Includes image quidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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)

19

Image /page/19/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are small white accents or highlights around the letters and the inner edge of the circle, giving the logo a three-dimensional appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9T/9T-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Modes	Combined Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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) Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
(6) 3D/4D Imaging mode
Includes image quidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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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 E80 / Vivid E90 / Vivid E95 with P2D Transducer

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

	Mode of Operation
Clinical Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac			P	P	[3]
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). (5)
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- [8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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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 E80 / Vivid E90 / Vivid E95 with P6D Transducer

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

| Clinical Application

Anatomy/ Region of Interest	Mode of Operation
	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac			P	P							[3]
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication

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
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode [6]
Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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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510(k) Summary

| | In accordance with 21 CFR 807.92 the following summary of information is provided:
March 15, 2017 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date:
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: | Jan Tore Thollefsen
Regulatory Affairs Manager
GE Vingmed Ultrasound AS |
| Device:
Trade Name:
Common/Usual Name:
Classification Names: | Vivid E80, Vivid E90, Vivid E95
Diagnostic Ultrasound System
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 |
| Primary Predicate Device:
Secondary Predicate
Device(s): | Vivid E80, Vivid E90, Vivid E95 (K150087)
LOGIQ E9 (K163077)
Vivid S60, Vivid S70 (K142323)
TomTec Arena TTA2 (K150122) |
| Device Description: | Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3
diagnostic ultrasound systems primarily intended for cardiac
imaging and analysis, but which also includes vascular and
general radiology applications. The Vivid E80 / Vivid E90 /
Vivid E95 incorporates a variety of electronic array transducers
operating in linear, curved linear, sector/phased array or matrix
array format, including two dedicated CW transducers. Vivid E80
will support 2D imaging, while Vivid E90 and Vivid E95 will
support real time 3D imaging in addition to 2D, and incorporate
several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid
95 consists of a mobile console with keyboard control panel;
color LCD/TFT touch panel, OLED color video display, DVI
connector for optional external video display, and optional image
storage and printing devices. It provides high performance
ultrasound imaging and analysis and has comprehensive
networking and DICOM capability. |

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Intended Use:	Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Technology:	The Vivid E80 / Vivid E90 / Vivid E95 employs the same fundamental scientific technology as its predicate devices.
Determination of Substantial Equivalence:	Comparison to Predicate Devices The Vivid E80 / Vivid E90 / Vivid E95 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

Intended Use:

Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Technology:

The Vivid E80 / Vivid E90 / Vivid E95 employs the same fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Comparison to Predicate Devices The Vivid E80 / Vivid E90 / Vivid E95 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

Musculo-skeletal Superficial is added as an expansion to ● already cleared Musculo-skeletal Conventional the indication on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
There has also been expansion of the indications for individual transducers with this submission. Beside the Musculo-skeletal Superficial which was added to the system, all such added indications for transducers are within the set of clinical applications already cleared for the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087), and none of the added applications will change the body surface type or the patient contact time for any of the affected transducers compared to their already cleared indication.
The new feature "Myocardial Work" builds on the functionality of the existing "2D-Strain" functionality available with the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
The new features "4D Auto RVQ" and "4D Auto MVQ" are both alternative implementation of functionality offered with TomTec Arena (K150122) as available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).

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Image /page/24/Picture/0 description: The image shows the logo for GE Healthcare. The text is in a serif font and is black. The words "GE" and "Healthcare" are next to each other.

Image /page/24/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of curved lines, resembling water droplets or stylized flames, which add a dynamic element to the design.

510(k) Premarket Notification Submission

"Cardiac AutoDoppler", "FlexiViews" and "QuickApps" . are workflow improvements of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087)
"Blood Speckle Imaging" (BSI) is a new tool that gives the user the option to display graphical presentation of blood flow trajectories in the heart ventricle beside traditional color flow.
"Virtual Convex" is a new imaging technique used with ● linear transducers as migrated from the predicate LOGIO E9 (K163077)
o WLAN functionality is offered as an alternative to the regular LAN offered with the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
. Picture-in picture viewing of an external video signal will be available through direct streaming from a VGADVI device. The video signal, which can be toggled On/Off by the user, is for visualization only.

Summary of Non-Clinical Tests:

Vivid E80 / Vivid E90 / Vivid E95 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 comply with applicable medical device safety standards. The Vivid E80 / Vivid E90 / Vivid E95 complies with voluntary standards:

. ANSI / AAMI ES60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/A1:2012
IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007.
IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007-08.
NEMA UD 3, Standard for Real Time Display of Thermal o and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
o ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009
IEC62359, Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical

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510(k) Premarket Notification Submission

indices related to medical diagnostic ultrasonic fields, 2010

ISO14971, Application of risk management to medical ● devices, 2007
NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016

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

Risk Analysis ●
Usability Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification) ●
Safety testing (Verification)
Simulated use testing (Validation)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Vivid E80 / Vivid E90 / Vivid E95 Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).