Predicate Devices

Reference Devices

Not Found.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with digital processing and analysis capabilities, but there is no mention of AI, ML, deep learning, or any related technologies in the intended use, device description, or performance studies summary.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound imaging and analysis." There is no mention of it being used for treatment or therapy.

Diagnostic

Yes

The Device Description explicitly states: "Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system..."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console with hardware components like a control panel, touch panel, display monitor, and includes various electronic array transducers. It also mentions hardware for image storage and printing. This is clearly a hardware-based ultrasound 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 S60N/Vivid S70N is an 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. This aligns with the function of an ultrasound system, not an IVD.

Therefore, the Vivid S60N/Vivid S70N 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 S60N/Vivid S70N 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 for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & 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); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).

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

Clinical Application / Anatomy/Region of Interest: Ophthalmic, Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other (Urology/Prostate)

Exam Type, Means of Access: Transesophageal, Transrectal, Transvaginal, Intraoperative, Intracardiac and Intraluminal, Tissue Biopsy, Vascular Access (IV, PICC)

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

IYN, IYO, ITX

Device Description

Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.

The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer.

Mentions image processing

Yes. "ultrasound signal processing" and "cSound 2.0" is an improvement of the existing cSound software image processing platform.

Mentions AI, DNN, or ML

Not Found.

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics; Abdominal (Including Renal & 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); Transesophageal; Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular)

Indicated Patient Age Range

Not Found. (However, "Adult and Pediatric" is mentioned for Cardiac application and "Neonatal Cephalic" for neurological imaging.)

Intended User / Care Setting

qualified physician, Not Found.

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

Not Found.

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

Not Found.

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

Summary of Non-Clinical Tests:
Vivid S60N / Vivid S70N were evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The Vivid S60N / Vivid S70N comply with voluntary standards:

ANSI / AAMI ES60601-1, Medical Electrical Equipment . - Part 1: General Requirements for Safety, 2005/A1:2012
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: ● general Requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015.
ISO 10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
IEC 62359, Ultrasonics Field characterization Test . methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
ISO 14971, Application of risk management to medical devices, 2007
NEMA PS3.1-3.20, 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) .

Transducer materials and other patient contact materials are biocompatible.

Successful results and compliance of the described non-clinical tests ensure the differences between the predicate device and the subject device do not affect the safety and effectiveness and are substantially equivalent to the predicate devices.

Summary of Clinical Tests:
The subject of this premarket submission, Vivid S60N / Vivid S70N, 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.

K170878, K173341, K163077

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 19, 2018

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

Re: K182450

Trade/Device Name: Vivid S60N, Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 6, 2018 Received: September 7, 2018

Dear Tracey 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hse 2. Mild

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182450

Device Name Vivid S60N, Vivid S70N

Indications for Use (Describe)

Vivid S60N/Vivid S70N 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 for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & 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); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal 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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters and the edge of the circle. The logo is simple and recognizable, and it is associated with a well-known and established company.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S60N / Vivid S70N. Combinations identified as "P" represent those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Vivid S60N / Vivid S70N Transducer: 3Sc-RS Transducer: 6S-D Transducer: 12S-D Transducer: 9L-D Transducer: 11L-D Transducer: L8-18i-D Transducer: C1-6-D Transducer: C1-5-D Transducer: C2-9-D Transducer: C3-10-D Transducer: iC5-9-D Transducer: 6VT-D Transducer: 6Tc-RS Transducer: 9T-RS Transducer: 10T-D Transducer: P2D Transducer: P6D Transducer: M5Sc-D (only on Vivid S70N) Transducer: AcuNav 10F (G version) Transducer: AcuNav 8F (G version) Transducer: SOUNDSTAR 3D 10F (G version) Transducer: SOUNDSTAR eco 8F (G version) Transducer: SOUNDSTAR eco 10F (G version)

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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 script, enclosed within a circular frame. The frame is decorated with curved, teardrop-shaped elements, giving it a distinctive and recognizable appearance. The logo is presented in a blue color scheme.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	P	P	P	P	P	P	P	P	P	P	[8,9]
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[8,9,1,2]
Abdominal	P	P	P	P	P	P	P	P	P	P	[8,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8,9]
Small Organ	P	P	P	P	P	P	P	P	P	P	[3,8]
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	[9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[4,6,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8,9]
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	[5,8,9]
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	P	[8]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[8]
Transuretheral
Intraoperative	N	N	N	N	N	N	N	N	N	N	[10]
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8,9]
Vascular Access (IV, PICC)	P	P	P	P	P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K16307); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; .

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

Abdominal includes Aorto-Iliac Arterv [2]

Small organ includes breast, testes, thyroid. (3)

[4] Cardiac is Adult and Pediatric.

Other use includes Urology/Prostate [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

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

5

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Four decorative, teardrop-shaped elements are spaced evenly around the outside of the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the well-known multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[8,1]
Pediatric	P	P	P	P	P	P	P	P	P	[8]
Small Organ
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
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Artery [2]

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

Cardiac is Adult and Pediatric. [4]

[5] Other use includes Urology/Prostate
[6] 3D/4D Imaging mode

Notes:

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 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

6

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Four decorative, teardrop-shaped elements are spaced evenly around the outside of the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the well-known multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	P	P	P	P	P	P	P	P	P	P	[9,1]
Abdominal	P	P	P	P	P	P	P	P	P	P
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	[4,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Artery [2]

[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]

[5] Other use includes Urology/Prostate

[6] 3D/4D Imaging mode

Notes:

[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 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative elements resembling stylized lightning bolts or arcs around its perimeter.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Anatomy/Region of Interest
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	[5,8]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P	[8]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[8]
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2]

[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric

ાંકા Other use includes Urology/Prostate

[6] 3D/4D Imaging mode

Notes:

[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 al

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script font in the center. There are also some wave-like designs around the letters. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

GE Vivid S60N / Vivid S70N 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	[1,8,2]
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	[5,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2]

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

[4] Cardiac is Adult and Pediatric.

ાંકી Other use includes Urology/Prostate

3D/4D Imaging mode ાંદા

Notes:

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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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. The letters are also blue, and there are white accents around the perimeter of the circle, giving it a three-dimensional appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[8,1]
Pediatric	P	P	P	P	P	P	P	P	P	[8]
Small Organ	P	P	P	P	P	P	P	P	P	[3,8]
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
Intracardiac and Intraluminal
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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 =

previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes: [1] Abdominal includes renal. GYN/Pelvic

Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorta, Iliac Artery

Abdominal includes Aorto-Iliac Artery (21

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

Cardiac is Adult and Pediatric [4]

151 Other use includes Urology/Prostate

[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 ાં છો

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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/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, and there are white accents around the perimeter of the circle, giving it a three-dimensional appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[3,8]
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
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Artery [2]

Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.

Other use includes Urology/Prostate [5]

।ମା 3D/4D Imaging mode

Notes:

[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] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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
Small Organ	P1	P1	P1	P1	P1	P1	P1	P1	P1	[2,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P1	P1	P1	P1	P1	P1	P1	P1	P1	[8]
Musculo-skeletal Conventional	P1	P1	P1	P1	P1	P1	P1	P1	P1	[8]
Musculo-skeletal Superficial	P1	P1	P1	P1	P1	P1	P1	P1	P1	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P1	P1	P1	P1	P1	P1	P1	P1	P1	[10,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 =

previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Abdominal includes Aorto-Iliac Artery

Small organ includes breast, testes, thyroid. [3]

[4] Cardiac is Adult and Pediatric.

ાંકા Other use includes Urology/Prostate

[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 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 'GE' intertwined in a stylized script, enclosed within a circular frame. The frame has a pattern of stylized swirls or petals around the edge. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form

GE Vivid S60N / Vivid S70N with 3Sc-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	P	P	P	P	P	P	P	P	P	P	[9]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,2,9]
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	[4,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[9]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

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

Abdominal includes Aorto-Iliac Artery [2]

Small organ includes breast, testes, thyroid. [3]

Cardiac is Adult and Pediatric. [4]

[5] Other use includes Urology/Prostate

161 3D/4D Imaging mode

Includes image quidance for freehand needle placement [7]

[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD

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

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, and there are white accents around the perimeter of the circle, giving it a three-dimensional appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[1,9]
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	[4,9]
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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
[5] Other use includes Urology/Prostate
[6] 3D/4D Imaging mode

Notes:

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 ાં છો

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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" in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns around the edge.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[8]
Abdominal	P	P	P	P	P	P	P	P	P	[1, 2, 8]
Pediatric	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	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	[5,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

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

Abdominal includes Aorto-Iliac Artery [2]

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

[4] Cardiac is Adult and Pediatric.

ાંકા Other use includes Urology/Prostate
[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 ાં છો

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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) Prescription User (Per 21 CFR 801.109)

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns around the edge.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with C1-5-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										[8]
Fetal / Obstetrics	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Abdominal	P2	P2	P2	P2	P2	P2	P2	P2	P2	[1, 2, 8]
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P2	P2	P2	P2	P2	P2	P2	P2	P2	[5,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P2	P2	P2	P2	P2	P2	P2	P2	P2	[7,8]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

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

Abdominal includes Aorto-Iliac Artery (2)

[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.

Other use includes Urology/Prostate [5]

3D/4D Imaging mode ાં દિવ

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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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) Prescription User (Per 21 CFR 801.109)

16

Image /page/16/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. The logo is enclosed within a circular border with decorative swirls around the perimeter. The color scheme is primarily blue and white.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery 121

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

[4] Cardiac is Adult and Pediatric.

[5] Other use includes Urology/Prostate

3D/4D Imaging mode [6]

Notes:

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 ાં છો

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative, teardrop-shaped elements around its perimeter, giving it a distinctive and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 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
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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Arterv [2]
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
[5] Other use includes Urology/Prostate
[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
ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script. The logo is enclosed within a circular border with decorative swirls around the perimeter. The color scheme is primarily blue and white.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 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	[9, 4]
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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

[1] Abdominal includes renal, GYN/Pelvic

Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
[5] Other use includes Urology/Prostate
[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

ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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) Prescription User (Per 21 CFR 801.109)

19

Image /page/19/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 border has decorative elements resembling small petals or leaves, evenly spaced around the circle. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	P3	P3	P3	P3	P3	P3	P3	P3	P3	P3	[4,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P3	P3	P3	P3	P3	P3	P3	P3	P3	P3	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

Notes: Abdominal includes renal, GYN/Pelvic 11

Abdominal includes Aorto-Iliac Artery [2]

[3] Small organ includes breast, testes, thyroid. Cardiac is Adult and Pediatric.

[4] ાંડી

Other use includes Urology/Prostate [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]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

20

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame is decorated with curved, teardrop-shaped elements, giving it a distinctive and recognizable appearance. The logo is presented in a blue color scheme.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[4]
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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2] Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate 151
[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]

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

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has four small white flourishes around the edge, one at each cardinal direction. The blue color is a medium shade, and the overall design is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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	[4]
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
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

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

Abdominal includes Aorto-Iliac Artery [2]
Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
[5] Other use includes Urology/Prostate
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M. B/Color M. B/PWD or CWD. B/Color/PWD or CWD. B/Power/PWD 191
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

22

Image /page/22/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 frame has decorative elements resembling stylized water droplets or floral patterns. The logo is presented in a blue color scheme, with the letters and frame in a lighter shade of blue against a slightly darker blue background.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with AcuNav 10F (G version) 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
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
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

Abdominal includes renal, GYN/Pelvic [1]

[2] Abdominal includes Aorto-Iliac Artery
Small organ includes breast, testes, thyroid. [3]

[4] Cardiac is Adult and Pediatric.

[5] Other use includes Urology/Prostate
[6] 3D/4D Imaging mode

Notes:

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 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

23

Image /page/23/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 frame has decorative elements resembling stylized water droplets or floral patterns. The logo is presented in a blue color scheme, with the letters and frame in a lighter shade of blue against a slightly darker blue background.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with AcuNav 8F (G version) 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
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
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2]
Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate 151
[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]

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

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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 General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR 3D 10F (G version) Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/ Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse	[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
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
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2]
Small organ includes breast, testes, thyroid. [3]

Cardiac is Adult and Pediatric. [4]

Other use includes Urology/Prostate 151
[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]

191 Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

25

Image /page/25/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' written in a stylized script inside. The letters are interconnected and have a flowing, cursive appearance. The circle is bordered by a series of small, teardrop-shaped elements, also in blue, that create a decorative effect around the central letters.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR eco 10F (G version) 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
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
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2]
Small organ includes breast, testes, thyroid. [3]

[4] Cardiac is Adult and Pediatric.

[5] Other use includes Urology/Prostate
[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 191

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

26

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are four small circles placed symmetrically around the intertwined letters, adding a decorative element to the design. The logo is rendered in a blue color.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with SOUNDSTAR eco 8F (G version) Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/ Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse	[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
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
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P	[9]
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes:

Abdominal includes renal, GYN/Pelvic [1]

Abdominal includes Aorto-Iliac Artery [2] Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate 151
[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]

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

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

27

Image /page/27/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.

Diagnostic Ultrasound Indications for Use Form GE Vivid S70N 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	[1,2,9]
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	[4,9]
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	[5,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[9]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;

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

Abdominal includes Aorto-Iliac Artery [2]

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

Cardiac is Adult and Pediatric. [4]

Other use includes Urology/Prostate [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 181

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

[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)

System may provide 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)

28

Image /page/28/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. There are also some white swirls around the letters.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	September 6, 2018
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
tracey.ortiz@ge.com
Secondary Contact Person:	Carmel Lehrer
Regulatory Affairs Specialist
GE Vingmed Ultrasound AS
Trade Name:	Vivid S60N, Vivid S70N
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 S60N, Vivid S70N (K170878)
Secondary Predicate
Device(s):	Vivid E95 (K173341)
LOGIQ E9 (K163077)
Device Description:	Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound
system, which is primarily intended for cardiac imaging and
analysis but also includes vascular and general radiology
applications. It is a full featured diagnostic ultrasound system that
provides digital acquisition, processing, analysis and display
capability.
	The Vivid S60N / Vivid S70N consists of a mobile console with a
height-adjustable control panel, color LCD touch panel, LCD
display monitor and optional image storage and printing devices.
It includes a variety of electronic array transducers operating in
linear, curved, sector/phased array, matrix array or dual array
format, including dedicated CW transducers and real time 3D
transducer.

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The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

Vivid S60N/Vivid S70N is a general-purpose ultrasound system, Intended Use: 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 for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & 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); Transesophageal; Transvaginal; Transrectal: Intra-cardiac: Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).

The Vivid S60N / Vivid S70N employs the same fundamental Technology: scientific technology as its predicate devices.

Comparison to Predicate Devices Determination of Substantial Equivalence: The Vivid S60N / Vivid S70N is substantially equivalent to the predicate devices with regard to intended use, imaging

capabilities, technological characteristics and safety and effectiveness.

The following is an overview of the differences between the proposed Vivid S60N / Vivid S70N and its predicates. Transducers:

. Adding transducers: C1-5-D convex array transducer previously cleared in LOGIQ E9 (K163077) and L8-18i-D linear transducer previously cleared in Vivid E95 (K173341)
Removed transducer M5Sc-D from Vivid S60N ●

Indications for Use:

. Adding new indication for use: Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
Features/Functionality:
. The new feature "4D Marker" allows the user to manually place annotations/markers into 3D/4D datasets on the system when upgraded to 4D. This is an extension of

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510(k) Premarket Notification Submission

existing image annotation capabilities on the predicate Vivid S60N / Vivid S70N (K170878).

2.0 provide workflow . "AFI 2.0" and "AutoEF improvements of functionality already cleared on the predicate Vivid S60N / Vivid S70N (K170878).
Two additional sets of Z-score values are added, based on published literature, to the "Z Score" functionality cleared in predicate Vivid S60N / Vivid S70N (K170878).
. "Stream Server" functionality is added for streaming 2D and 4D ultrasound data real time over LAN or WLAN network connection, using secure authentication and encryption. Real-time remote viewing was previously cleared (K170878). The stream server expands the viewing capability to an enabled device that is not physically connected to the system.
"Tricefy Uplink" is available with the subject Vivid S60N ● / Vivid S70N enabling data flow to the Tricefy Cloud service. Both Tricefy Uplink and Tricefy are products of Trice Imaging Inc.
The software features of the subject Vivid S60N / Vivid ● S70N are installed and are running under Windows 10 Embedded Operating software environment. This is substantially equivalent to the cleared Vivid S60N / Vivid S70N (K170878) where the software features were installed and were running under Windows 7 Embedded.
"Whitelisting" is implemented on the subject Vivid S60N / ● Vivid S70N. Whitelisting is a cyber security technology available with Windows 10 Embedded and is implemented as additional protection against running and infecting the ultrasound system with malware. The addition of "Whitelisting" will have no impact on the safety or effectiveness of the clinical functionality of the systems.
"Flexible video out" is an enhancement of the external ● video out capability that was cleared in predicate Vivid S60N/S70N (K170878). Flexible video out will allow the image to be scaled to fit the external monitor.
. "cSound 2.0" is an improvement of the existing cSound software image processing platform. The functionality is the same as what was cleared in predicate Vivid S60N/S70N (K170878).

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Summary of Non-Clinical Tests:

Vivid S60N / Vivid S70N were evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. The Vivid S60N / Vivid S70N comply with voluntary standards:

ANSI / AAMI ES60601-1, Medical Electrical Equipment . - Part 1: General Requirements for Safety, 2005/A1:2012
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: ● general Requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015.
ISO 10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
IEC 62359, Ultrasonics Field characterization Test . methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
ISO 14971, Application of risk management to medical devices, 2007
NEMA PS3.1-3.20, 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) .

Transducer materials and other patient contact materials are biocompatible.

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Successful results and compliance of the described non-clinical tests ensure the differences between the predicate device and the subject device do not affect the safety and effectiveness and are substantially equivalent to the predicate devices.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Vivid S60N / Vivid S70N to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).