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/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.

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. 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.

AI/ML Overview

This document is a 510(k) Premarket Notification submission for the GE Vivid S60N and Vivid S70N Diagnostic Ultrasound Systems, specifically outlining their indications for use and a summary of non-clinical tests. It states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity for diagnostic tasks.

The document focuses on demonstrating substantial equivalence to predicate devices for its intended uses and assuring safety through engineering and quality assurance tests.

Here's the breakdown of the information requested, based on the provided document:

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

The document does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for any specific clinical application. Instead, it lists various standard compliance points for safety and an overall claim of "substantially equivalent" performance to predicate devices.

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

Not applicable, as no clinical performance study for diagnostic criteria is described. The document states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical performance study for diagnostic criteria is described.

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

Not applicable, as no clinical performance study for diagnostic criteria is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document states that clinical studies were not required. The product is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations. While it mentions new features like "4D Auto MVO" and "4D Auto AVQ" and "Cardiac AutoDoppler" as "functionality" or "workflow improvements" migrated from other predicate devices, it does not detail any comparative effectiveness study for these features.

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

Not applicable. This device is a diagnostic ultrasound system that requires a human operator and physician for image acquisition and interpretation, respectively. There is no mention of a standalone algorithm performance.

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

Not applicable, as no clinical performance study for diagnostic criteria is described.

8. The sample size for the training set

Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission. The mention of "new functionality" being "migrated" suggests these may have been developed and tested previously as part of other predicate device submissions or internal development, but details are not provided here.

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

Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission.

Summary from the document:

The GE Vivid S60N and Vivid S70N are general-purpose ultrasound systems. The submission demonstrates substantial equivalence to previously cleared predicate devices (Vivid S60/S70, Vivid E80/E90/E95, Vivid iq, LOGIQ E9, TomTec Arena TTA2) based on:

Intended Use: Similar to predicate devices, specialized for cardiac imaging but also covers vascular and general radiology. The document expands on previously cleared indications for use by adding specific applications from other predicate devices (e.g., Intra-cardiac, Intra-luminal, Transvaginal, Transrectal, Musculo-skeletal Superficial).
Technological Characteristics: Employs the same fundamental scientific technology. New features ("4D Auto MVO," "4D Auto AVQ," "Cardiac AutoDoppler," "FlexiViews," "QuickApps," "Virtual Convex," "View-X") are presented as alternative implementations, new functionalities, workflow improvements, or migrated techniques from other cleared devices.
Safety and Effectiveness: Compliance with numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety (e.g., ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). Quality assurance measures were applied, including risk analysis, usability analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).

The key takeaway is that this 510(k) submission relies on demonstrating substantial equivalence to existing, cleared devices through non-clinical testing and shared technology, rather than presenting novel clinical performance data for new diagnostic accuracy claims.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC June 14, 2017 TRACEY ORTIZ REGULATORY AFFAIRS DIRECTOR 9900 W. INNOVATION DRIVE WAUWATOSA, WI 53226

Re: K170878

Trade/Device Name: Vivid S60N. Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: May 15, 2017 Received: May 16, 2017

Dear Ms. Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

Sincerely yours.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170878

Device Name Vivid S60N, Vivid S70N

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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

FOR FDA USE ONLY

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

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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 S60N / Vivid S70N. 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:

Transducer: 3Sc-RS Transducer: M5Sc-D Transducer: 6S-D Transducer: 12S-D Transducer: 9L-D Transducer: 11L-D Transducer: C1-6-D Transducer: C2-9-D

System: Vivid S60N / Vivid S70N

Transducer: C3-10-D
Transducer: iC5-9-D
Transducer: 6VT-D
Transducer: 6Tc-RS
Transducer: 9T-RS
Transducer: P2D
Transducer: P6D
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 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 there are four small white teardrop shapes around the letters. The logo is simple and recognizable, and it is associated with a well-known company.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic	N	N	N	N	N	N	N	N	N	N	[8,9]
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	[8,9,1,2]
Abdominal	N	N	N	N	N	N	N	N	N	N	[8,9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[8,9]
Small Organ	N	N	N	N	N	N	N	N	N	N	[3,8]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	[8,9]
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	[,9]
Cardiac	N	N	N	N	N	N	N	N	N	N	[4,6,9]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[8,9]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[8]
Other	N	N	N	N	N	N	N	N	N	N	[5,8,9]
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N	[6,9]
Transrectal	N	N	N	N	N	N	N	N	N	N	[8]
Transvaginal	N	N	N	N	N	N	N	N	N	N	[8]
Transuretheral	N	N	N	N	N	N	N	N	N	N
Intraoperative	N	N	N	N	N	N	N	N	N	N
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N
Intravascular	N	N	N	N	N	N	N	N	N	N
Interventional Guidance	N	N	N	N	N	N	N	N	N	N
Intracardiac and Intraluminal	N	N	N	N	N	N	N	N	N	N	[9]
Tissue Biopsy	N	N	N	N	N	N	N	N	N	N	[7,8,9]
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	N	[8]

P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq

(K161706); N = New indication.

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

[2] Abdominal includes Aorto-Iliac Artery

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

[4] Cardiac is Adult and Pediatric.

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]

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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Diagnostic Ultrasound Indications for Use Form GE Vivid 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	N	N	N		N	N	N	N	N	N	[8,1]
Pediatric	P1	P1	P1		P1	N	P1	P1	P1	P1	[8]
Small Organ
Neonatal Cephalic	P1	bl	P1		b1	N	ь1	ь1	P1	P1	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P1	P1	P1		P1	N	P1	P1	P1	P1	[8]
Musculo-skeletal Conventional	N	N	N		N	N	N	N	N	N	[8]
Musculo-skeletal Superficial	P1	P1	P1		P1	N	P1	P1	P1	P1	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P1	ь1	P1		ь1	N	ь1	b1	N	N	[7,8]
Vascular Access (IV, PICC)	P1	P1	P1		P1	N	P1	P1	N	N	[8]

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

Abdominal includes Aorto-Iliac Artery [2]

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

Other use includes Urology/Prostate ાં છે.

[6] 3D/4D Imaging mode

[7] Includes image guidance for freehand needle placement

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

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

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/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 swirls or flourishes 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.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	P	P	P	P	[9,1]
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)

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

[2] Abdominal includes Aorto-Iliac Artery

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

[4] Cardiac is Adult and Pediatric.

Other use includes Urology/Prostate ાં છે.

[6] 3D/4D Imaging mode

[7] Includes image guidance for freehand needle placement

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

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are four small, stylized flourishes or embellishments evenly spaced around the outside of the circle. The logo is rendered in a blue color.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P2	P2	P2		P2	P2	P2	P2	P2	P2	[8]
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
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	P2	P2	P2		P2	P2	P2	P2	N	P2	[8]
Transvaginal	P2	P2	P2		P2	P2	P2	P2	N	P2	[8]
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P2	P2	P2		P2	P2	P2	P2	N	P2	[7,8]
Vascular Access (IV, PICC)	P2	P2	P2		P2	P2	P2	P2	N	P2	[8]

Notes: [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

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 181

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

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/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Abdominal	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[1,8,2]
Pediatric	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P2	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	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	P2	[7,8]
Vascular Access (IV, PICC)	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]

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

[2] Abdominal includes Aorto-Iliac Artery

[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate [5]
3D/4D Imaging mode 161
[7] Includes image quidance 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 ાં છો

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/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1	[8,1]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ	P	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	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[7,8]
Vascular Access (IV, PICC)	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]

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 ાં છે.

[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 [a]

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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Small Organ	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[3,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Musculo-skeletal Conventional	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[7,8]
Vascular Access (IV, PICC)	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[8]

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 ાં છે.

[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 [a]

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	N	N	N	N	N	N	N	N	N	N	[9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[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)

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 ાં છે.

[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 [a]

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{12}------------------------------------------------

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

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Modes	Combined HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P3	P3	P3	P3	P3	P3	P3	P3	P3	N	[9]
Abdominal	P3	P3	P3	P3	P3	P3	P3	P3	P3	N	[1,2,9]
Pediatric	P3	P3	P3	P3	P3	P3	P3	P3	P3	N	[9]
Small Organ
Neonatal Cephalic
Adult Cephalic	P3	P3	P3	P3	P3	P3	P3	P3	P3	N	[a]
Cardiac	P3	P3	P3	P3	P3	ьз	P3	P3	P3	N	[4,9]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	[a]
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	P3	P3	N	P3	N	P3	P3	P3	P3	N	[9]
Vascular Access (IV, PICC)

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

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]

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]

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable 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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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)

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 ાં છે.

[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 [a]

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes 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.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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, 2, 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	[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)

Notes: 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.

Other use includes Urology/Prostate [5]

ાદા 3D/4D Imaging mode

|71 Includes imaqe quidance for freehand needle placement

181 Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are small, white, curved shapes around the outer edge of the circle, giving it a slightly textured or decorative appearance. The logo is simple, recognizable, and commonly associated with the multinational conglomerate.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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)

Notes: [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

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 181

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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)

Notes: 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.

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]

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[9, 4]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Intracardiac and Intraluminal
Tissue Biopsy
Vascular Access (IV, PICC)

Notes: 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.

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]

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

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/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 small decorative elements resembling stylized leaves or flourishes placed around the circle. The logo is presented in a blue color.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac			P2	P							[4]
Peripheral Vascular			P2	P2
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)

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

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]

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]

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the 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 flourishes at the cardinal points (top, bottom, left, and right), giving it a classic and recognizable appearance.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac			P2	P2							[4]
Peripheral Vascular			P2	P2
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)

Notes: [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
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 181

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

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)

{20}------------------------------------------------

Image /page/20/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 also some white swirls around the letters. The logo is simple and recognizable.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	P3	P3	P3	P3	P3	P3	P3	P3	P3	P3	[9]
Tissue Biopsy
Vascular Access (IV. PICC)

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

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]

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]

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

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/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 small, rounded shapes at the four cardinal points around the circle.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	P3	P3	P3	P3	P3	P3	P3	P3	P3		[9]
Tissue Biopsy
Vascular Access (IV. PICC)

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

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]

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]

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

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/22/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. There are small white flourishes around the edge of the circle. 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 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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	P3	P3	P3	P3	P3	P3	P3	P3	P3		[9]
Tissue Biopsy
Vascular Access (IV, PICC)

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

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]

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]

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

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/23/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. There are small white flourishes around the edge of the circle. 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 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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	P3	P3	P3	P3	P3	P3	P3	P3	P3	P3	[9]
Tissue Biopsy

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

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]

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]

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

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/24/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. There are four white flourishes, one each at the top, bottom, left, and right of the circle.

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 ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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	P3	P3	P3	P3	P3	P3	P3	P3	P3		[9]
Tissue Biopsy
Vascular Access (IV, PICC)

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

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]

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]

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

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/25/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. The circle has a decorative border around it. 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:	March 23, 2017
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120F:(414)918-8275
Secondary Contact Person:	Carmel LehrerRegulatory Affairs SpecialistGE Vingmed Ultrasound AS
Device:
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-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate Device:	Vivid S60, Vivid S70 (K142323)
Secondary PredicateDevice(s):	Vivid E80, Vivid E90, Vivid E95 (K150087)Vivid iq (K161706)LOGIQ E9 (K163077)TomTec Arena TTA2 (K150122)
Device Description:	Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasoundsystem, which is primarily intended for cardiac imaging andanalysis but also includes vascular and general radiologyapplications. It is a full featured diagnostic ultrasound system thatprovides digital acquisition, processing, analysis and displaycapability.The Vivid S60N / Vivid S70N consists of a mobile console with aheight-adjustable control panel, color LCD touch panel, LCDdisplay monitor and optional image storage and printing devices.It includes a variety of electronic array transducers operating inlinear, curved, sector/phased array, matrix array or dual arrayformat, including dedicated CW transducers and real time 3Dtransducer.

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Image /page/26/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 shape. The circle is made up of swirling, wave-like lines, giving it a dynamic and fluid appearance. The logo is presented in a blue color scheme.

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 and Intra-luminal.

Technology: The Vivid S60N / Vivid S70N employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices Substantial Equivalence: The Vivid S60N / Vivid S70N systems are substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
. The transducers used on the proposed Vivid S60N / Vivid S70N systems include all the transducers used on the predicate Vivid S60 / Vivid S70 (K142323) and include those added under Appendix E: 9T-RS, 3Sc-RS, 11L-D, P6D, C2-9-D, C3-10-D.
Adding 5 ICE (Intra-CardiacEchocardiography) probes that were previously cleared on Vivid ig (K161706).
Adding IC5-9-D probe previously cleared on Vivid E95/E90/E80 (K150087). The proposed Vivid S60N / Vivid S70N expands on the indications for use of Vivid S60 / Vivid S70 (K142323) and adds Intra-cardiac, Intra-luminal, Transvaginal, Transrectal, Musculo-skeletal Superficial from the cleared Vivid iq (K161706).
The new feature "4D Auto MVO" is an alternative ● implementation of functionality offered with TomTec Arena

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GE Healthcare

Image /page/27/Picture/1 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "ge" in a stylized, cursive font. The letters are white and are surrounded by a blue background. There are decorative swirls around the circle.

510(k) Premarket Notification Submission

(K150122) as available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).

"4D Auto AVQ" is a new functionality migrated from the ● predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087).
"Cardiac AutoDoppler", "FlexiViews" and "QuickApps" are ● workflow improvements of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K150087)
. "Virtual Convex" is a new imaging technique used with linear transducers as migrated from the predicate LOGIQ E9 (K163077)
View-X: Picture-in picture viewing of an external video signal will be available through direct streaming from a VGADVI device. The video signal, which can be toggled On/Off by the user, is for visualization only.

Summary of Non-Clinical Tests:

Vivid S60N / Vivid S70N has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Vivid S60N / Vivid S70N 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
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004
ISO14971, Application of risk management to medical ● devices, 2007

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Image /page/28/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is blue, with the letters and border in a lighter shade of blue.

NEMA, Digital Imaging and Communications in Medicine ● (DICOM) Set. (Radiology), 2016
The following quality assurance measures were applied to the development of the system:
Risk Analysis
Usability Analysis ●
Requirements Reviews ●
. Design Reviews
Testing on unit level (Module verification) .
Integration testing (System verification) ●
Performance testing (Verification) ●
Safety testing (Verification) .
Simulated use testing (Validation)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

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

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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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