Vivid E80, Vivid E90, Vivid E95

• K Number: K173341
• Device Name: Vivid E80, Vivid E90, Vivid E95
• Manufacturer: GE Medical Systems
• Date Cleared: 2017-11-02 ( 9 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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/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).

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.

Predicate Devices

K170823

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose ultrasound system with advanced processing capabilities (GPU) for faster imaging, but it does not mention or describe any AI or ML components, algorithms, or training/testing data.

Therapeutic

No

The device is described as a "general-purpose ultrasound system" intended for "ultrasound imaging and analysis," and "diagnostic ultrasound systems." There is no indication that it is used for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that it is an "ultrasound system... for ultrasound imaging and analysis," and the "Device Description" explicitly calls it "Track 3 diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console with hardware components like a keyboard control panel, touch panel, video display, and connectors, in addition to incorporating electronic array transducers. This indicates it is a hardware system with integrated software, not a software-only device.

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 diagnostic method, meaning it is performed on a living organism.
• Intended Use: The intended use clearly describes imaging and analysis of various anatomical sites within the body. There is no mention of analyzing samples taken from the body.
• Device Description: The description focuses on the hardware and software used for generating and processing ultrasound images. It does not describe components or processes related to sample analysis.

Therefore, the Vivid E80 / Vivid E90 / Vivid E95 is a diagnostic imaging device, not an in vitro diagnostic device.

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

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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).

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 (K170823)

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

November 2, 2017

Re: K173341

Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 24, 2017 Received: October 25, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert 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)

K173341

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)

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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: 4Vc-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: 10T-D Transducer: P2D Transducer: P6D

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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.

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	[6,8,9,11]
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	P	P	P	P	P	P	P	P	P	P	[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 E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

• Small organ includes breast, testes, thyroid [2]
• Cardiac is Adult and Pediatric [3]
• Other use includes Urology/Prostate [4]
• 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]

• ləl 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
• [11] Fetal/Obstetrics includes Fetal Heart

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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around it. The logo is presented in a blue color scheme.

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	P	P	P	P	P	P	P	P	P	P	[8]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ
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	P	P	P	P	P	P	P	P	P	P	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
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 E90/Vivid E90/Vivid E95 (K170823); 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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/6/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 has a double border, with the inner border being a slightly lighter shade of blue. There are decorative white swirls around the letters, adding a touch of elegance to the design.

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	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 E90/Vivid E95 (K170823); N = New indication

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

• [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]
• [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]
• ાં છો 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
• [11] Fetal/Obstetrics includes Fetal Heart

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)

7

Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is rendered in a light blue color. The logo is simple, recognizable, and represents the General Electric brand.

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:

| 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	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[6,9,11]
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 E90/Vivid E95 (K170823); N = New indication

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

[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]

[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]

ાં છો 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

[11] Fetal/Obstetrics includes Fetal Heart

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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4Vc-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	N	N	N	N	N	N	N	N	N	N	[6,9,11]
Abdominal	N	N	N	N	N	N	N	N	N	N	[1,6,9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6,9]
Small Organ
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	[6,9]
Cardiac	N	N	N	N	N	N	N	N	N	N	[3,6,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	N	N	N	N	N	N	N	N	N	N	[4,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	N	N	N	N	N	N	N	N	N	N	[9]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[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]

[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

[11] Fetal/Obstetrics includes Fetal Heart

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)

9

Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns, giving it a classic and recognizable appearance.

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	[8,11]
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	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P		P	[8]
Transvaginal	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	[7,8]
Vascular Access (IV, PICC)	P	P	P		P	P	P	P		P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); 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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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)

10

Image /page/10/Picture/1 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. The letters are also blue and have a swirling design. The logo is simple and recognizable, and it is often used to represent the company.

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											[1,8,10]
Abdominal	P	P	P		P	P	P	P	P	P	[1,8,10]
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ (specify)	P	P	P		P	P	P	P	P	P	[8]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[8]
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
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	[8]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

[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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/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 has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the long-standing brand identity of General Electric.

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	[8,11]
Abdominal	P	P	P		P	P	P	P	P	P	[1,8,10]
Pediatric	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	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	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	[7,8]
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); 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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around it. The logo is presented in a blue color scheme.

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	P	P	P		P	P	P	P	P	P	[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	P	P	P		P	P	P	P	P	P	[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 E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

[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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the outside of the circle, giving it a classic and recognizable appearance.

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	P	P	P		P	P	P	P	P	P	[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 E90/Vivid E95 (K170823); 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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the outside of the circle, giving it a classic and recognizable appearance.

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	Modes	Combined Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[9,11]
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	P	P	P	P	P	P	P	P	P	P	[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 E90/Vivid E95 (K170823); N = New indication

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

[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]

• [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

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/1 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 is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable appearance.

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	[9,11]
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	P	[9]
Adult Cephalic
Cardiac	P	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 E90/Vivid E95 (K170823); N = New indication

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

• [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]
• [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]
• Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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

GE Healthcare

Image /page/16/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, and the circle has a double border, also in blue.

510(k) Premarket Notification Submission

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	[8,11]
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 E80/Vivid E90/Vivid E95 (K170823); 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 quidance 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 ાં છો
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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

GE Healthcare

Image /page/17/Picture/1 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle has a decorative border with curved lines. The logo is simple and recognizable, representing the well-known multinational conglomerate.

510(k) Premarket Notification Submission

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	[8]
Small Organ	P	P	P		P	P	P	P	P	P	[2,8]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[8]
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	P	P	P		P	P	P	P	P	P	[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 = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); 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 quidance 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 ાં છો
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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

Image /page/18/Picture/1 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 is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable appearance.

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 E90/Vivid E95 (K170823); N = New indication

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

• [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]

• [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]
• Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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)

19

Image /page/19/Picture/1 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. Surrounding the circle are decorative, swirling lines, giving the impression of motion or energy.

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	Combined Harmonic
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	[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 E80/Vivid E90/Vivid E95 (K170823); 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
  • ાંકી 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]
  • [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
  • [11] Fetal/Obstetrics includes Fetal Heart

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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Image /page/20/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative swirls, also in blue, giving the logo a classic and recognizable 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	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	[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 E80/Vivid E90/Vivid E95 (K170823); 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
  • ાંકી 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]
  • [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
  • [11] Fetal/Obstetrics includes Fetal Heart

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)

21

Image /page/21/Picture/1 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. The circle is surrounded by a series of curved, white lines that resemble water droplets or stylized leaves, giving the logo a distinctive and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 10T-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	N	N	N	N	N	N	N	N	N	N	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N	[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 E90/Vivid E95 (K170823); 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
  • ાંકી 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 81
  • [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
  • [11] Fetal/Obstetrics includes Fetal Heart

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)

22

Image /page/22/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is rendered in a light blue color. The logo is simple, recognizable, and represents the General Electric brand.

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 E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

• [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]
• [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]
• Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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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Image /page/23/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.

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:

	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							[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 E90/Vivid E95 (K170823); N = New indication

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

• [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]
• [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]
• Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
• [10] Abdominal includes Aorta-Iliac Artery
• [11] Fetal/Obstetrics includes Fetal Heart

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)

24

Image /page/24/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. The letters are in a stylized font, and there are decorative swirls around the circle. The logo is simple and recognizable, and it is associated with a well-known company.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	October 23, 2017
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:[phone]
F:[phone]
Secondary Contact Person:	Jan Tore Thollefsen
Regulatory Affairs Manager
GE Vingmed Ultrasound AS
Device: Trade Name:	Vivid E80, Vivid E90, Vivid E95
Common/Usual Name:	Diagnostic 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
Primary Predicate Device:	Vivid E80, Vivid E90, Vivid E95 (K170823)
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.
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.
	A new transducer, "4Vc-D", was added for use with
regular 2D and 4D imaging. The 4Vc-D is a matrix array
transducer which is built on design principles from the
predicate 4V-D, already cleared for use with Vivid E80,
Vivid E90 and Vivid E95 (K170823). 4Vc-D has reduced
physical dimensions and weight compared to the predicate
4V-D, and has identical indications for use.A new transducer, "10T-D", was added for use with
transesophageal pediatric or adult imaging. 10T-D has
the same indications for use as the predicate 9T
transducer already cleared with Vivid E80, Vivid E90

25

Image /page/25/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

and Vivid E95 (K170823).

• . A new "Vmax" option was added to offer a high performance Graphical Processing Unit (GPU) as an alternative to the standard GPU used in the predicate Vivid E80 / Vivid E90 / Vivid E95. This new GPU will provide a higher processing speed of the receiving ultrasound information, and thus enable higher 4D volume-rates in imaging.

26

Image /page/26/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. The letters are stylized and connected, and the circle has a wavy border. The logo is simple and recognizable, and it is associated with a well-known company.

Vivid E80 / Vivid E90 / Vivid E95 has been evaluated for acoustic Summary of Non-Clinical output, biocompatibility, cleaning and disinfection effectiveness Tests: 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 and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
• 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 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) ●

27

Image /page/27/Picture/0 description: The image shows the logo of General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like patterns, also in blue, giving the logo a dynamic and recognizable appearance.

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).