Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System by GE MEDICAL SYSTEMS ISRAEL LTD.

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.

Device Description

The Vivid S60/S70 is a Track 3 diagnostic ultrasound system, which is primarily intended for echocardiography imaging and analysis, with additional capability in vascular and general ultrasound imaging. The Vivid S60/S70 incorporates a variety of electronic array transducers that provide digital acquisition, processing and display capabilities, and operate in linear, curved linear, sector/ phased array format or matrix array format, including CW transducer and a real time 3D transducer. Vivid S60/S70 consists of a mobile console approximately 56 cm wide 77 cm deep and 120 cm high, and includes multiple electronic array transducers that provide digital acquisition, processing and display capabilities. The user interface includes a variable height rotatable, user control panel with specialized controls, a 19-inch wide screen LCD display and a separate 12.1-inch touch panel with a resolution of 1280x800 with multi-touch capabilities.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE Vivid S60/S70 Diagnostic Ultrasound System. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested regarding acceptance criteria and a study proving the device meets those criteria will not be present in the same way as for a novel device.

Here's an analysis based on the provided document, addressing the requested information where applicable:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the new device performs as safely and effectively as the predicate devices and shares similar technological characteristics and indications for use. There are no specific quantitative performance metrics provided as "acceptance criteria" in the sense of a novel device proving its effectiveness against a particular target. Instead, the performance is assessed by comparison to predicates.

The "reported device performance" is the statement of substantial equivalence to the predicate devices across various features and clinical applications.

Feature/Criterion	Predicate Device Performance (Implicitly Met)	Proposed Device Performance (Reported)
Intended Use	Diagnosis of specific anatomical regions and clinical applications.	Same as predicate devices, with some minor differences (e.g., Transrectal, Transvaginal, Intraoperative not listed for the new system, but many are "new" indications on the general form, implying expansion from a single predicate).
Imaging Capabilities	B, M, Color M, Color/Power Doppler, Pulsed & CW Doppler, Combined modes, Harmonic, Coded Pulse, Realtime 3D, Multi-plane.	Same as predicate devices.
Technological Characteristics	Fundamental scientific technology, probe array types.	Same fundamental scientific technology and probe array types.
Safety and Effectiveness	Electrical safety, EMC, biocompatibility, acoustic output, cleaning and disinfection.	Conforms with applicable safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
Track Level (FDA limits)	Track 3	Track 3 (within FDA limits)

Note: The tables in the document listing "N" for new indications, "P" for previously cleared, and "E" for added under appendix E show expansion of indications for different transducers compared to specific predicate clearances. The overall summary (Page 14) states the Vivid S60/S70 intended use is consistent with a range of applications, indicating a broad equivalence to multiple predicate devices.

2. Sample size used for the test set and the data provenance

No clinical test set was used for this 510(k) submission. The document explicitly states: "The subject of this premarket submission, Vivid S60/S70, did not require clinical studies to support substantial equivalence." (Page 17)

Data provenance for non-clinical tests would refer to the standards and engineering tests mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical studies were required, no ground truth was established by experts for a test set in this submission. The "ground truth" for a 510(k) is effectively the established performance and safety of the predicate devices.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware diagnostic ultrasound system, not a standalone algorithm.

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

For this 510(k) submission, the "ground truth" is the performance of the predicate devices, which have already been deemed safe and effective by the FDA. The submission demonstrates that the new device performs equivalently based on non-clinical engineering tests and comparison of technical specifications.

8. The sample size for the training set

Not applicable. This device is a standard diagnostic ultrasound system, not an AI/machine learning device that would require a training set.

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

Not applicable. This device is a standard diagnostic ultrasound system, not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

October 10, 2014

GE MEDICAL SYSTEMS ISRAEL LTD. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

Re: K142323

Trade/Device Name: Vivid S60/S70 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 18, 2014 Received: August 20, 2014

Dear Mr. Behn:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

12S-D	6S-D	P2D
9L-D	6VT-D	C1-6-D
M5Sc-D	6Tc/6Tc-RS

{1}------------------------------------------------

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.

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,

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K142323

Device Name

Vivid S60/S70 Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/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 decorative swirls or flourishes around the perimeter. The logo is colored in a light blue hue.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S60/S70 system.

Combinations identified "P" for the transducers represents those previously cleared with another GE Ultrasound system.

Combinations identified ''N'' for the transducers represents those that are new.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The logo is blue and white.

Diagnostic Ultrasound Indications for Use Form GE Vivid S60/S70 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	N
Abdominal [1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ[2]	N	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transuretheral
Intraoperative [5]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

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

{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 script, enclosed within a circular border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.

510(k) Premarket Notification Submission

GE Vivid S60/S70 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	Combined Modes	HarmonicImaging	CodedPulse	RT3DMode*
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K121063, K131514); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[ �] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

Page 3 of 10

{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 script, enclosed within a circular border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.

510(k) Premarket Notification Submission

GE Vivid S60/S70 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ[2]	P	P	P		P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E

Notes: [2] Small organ includes breast, testes, thyroid.

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

Page 4 of 10

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, surrounded by a circular frame with decorative elements. The logo is colored in a light blue hue, and the overall design is simple and recognizable.

510(k) Premarket Notification Submission

GE Vivid S60/S70 with M5Sc-D Transducer

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

	Mode of Operation
ClinicalApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	RT3DMode*
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E

Notes: [2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

{8}------------------------------------------------

Image /page/8/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 border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.

510(k) Premarket Notification Submission

GE Vivid S60/S70 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E

Notes: [2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[�] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

{9}------------------------------------------------

Image /page/9/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, swirling elements around the letters, giving it a classic and recognizable appearance.

GE Vivid S60/S70 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	P
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	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K141093); E = added under Appendix E

Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, surrounded by a circular frame with decorative elements. The logo is colored in a light blue hue, and the overall design is simple and recognizable.

GE Vivid S60/S70 with 6Tc/6Tc-RS Transducer **

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

Clinical ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	RT3DMode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P	P
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	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K121063); E = added under Appendix E

Notes: [3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

[**] 6Tc differs from 6Tc-RS only in the connector type.

Page 8 of 10

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

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in a blue color. The logo is simple and recognizable, representing the company's brand identity.

GE Vivid S60/S70 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	RT3DMode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]				P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E

Notes: [3] Cardiac is Adult and Pediatric.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

Page 9 of 10

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

Image /page/12/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 is surrounded by decorative swirls or flourishes, also in blue, giving the logo a classic and recognizable appearance.

GE Vivid S60/S70 with C1-6-D Transducer

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

	Mode of Operation
ClinicalApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	RT3DMode*
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (K123564); E = added under Appendix E

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

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

[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

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

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is colored in a light blue hue, and the background is white.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	August 18, 2014
Submitter:	GE Healthcare9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275
Alternate Contact Person:	Karin ShimoniRegulatory Affairs LeaderGE HealthcareT: +972-4-8519-619F: +972-4-8519-500
Device: Trade Name:	Vivid S60 and Vivid S70 Diagnostic Ultrasound System
Common/Usual Name:	Vivid S60, Vivid S70
Classification Names:	Class II
	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN
Product Code:	Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K1315141 Vivid E9 Diagnostic Ultrasound System.K121063 Vivid S5/S6 Diagnostic Ultrasound System.K141093 6VT-D Diagnostic Ultrasound Transducer.K123564 Logiq E9 Diagnostic Ultrasound System.
Device Description:	The Vivid S60/S70 is a Track 3 diagnostic ultrasound system,which is primarily intended for echocardiography imaging andanalysis, with additional capability in vascular and generalultrasound imaging. The Vivid S60/S70 incorporates a variety ofelectronic array transducers that provide digital acquisition,processing and display capabilities, and operate in linear, curvedlinear, sector/ phased array format or matrix array format,including CW transducer and a real time 3D transducer. VividS60/S70 consists of a mobile console approximately 56 cm wide77 cm deep and 120 cm high, and includes multiple electronicarray transducers that provide digital acquisition, processing anddisplay capabilities. The user interface includes a variable heightrotatable, user control panel with specialized controls, a 19-inchwide screen LCD display and a separate 12.1-inch touch panelwith a resolution of 1280x800 with multi-touch capabilities.

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

Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes surrounding the circle, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.

510(k) Premarket Notification Submission

The device is intended for use by a qualified physician for Intended Use: ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
Technology: The Vivid S60/S70 employs the same fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Comparison to predicate

The Vivid S60/S70 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

	Proposed DeviceVivid S60/S70	Predicate DeviceVivid E9 (K131514)
Indications and Clinical Applications:
• Fetal/Obstetrics;	✓	✓
• Abdominal (IncludingRenal & Gyn)	✓	✓
• Pediatric	✓	✓
• Small Organ (breast, testes,thyroid);	✓	✓
• Neonatal Cephalic;	✓	✓
• Adult Cephalic;	✓	✓
• Cardiac (adult andpediatrics);	✓	✓
• Peripheral Vascular;	✓	✓
• Musculo-skeletalConventional	✓	✓
• Urology (includingprostate);	✓	✓
• Transesophageal;	✓	✓
• Transrectal (TR);		✓
• Transvaginal (TV);		✓
• Intraoperative (abdominal,thoracic, & vascular).		✓
Probe Array:
Phased Array, Matrix Single CrystalPhased Array Probe, Linear, Curved,pencil (Doppler), Transesophageal	✓	✓

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

Image /page/15/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 letters are white and have a swirling design. The blue circle is surrounded by a thin white border.

Image modes:
B, M, Color M, Color/Power Doppler,Pulsed & CW Doppler, Combinedmodes: B/M, B/Color M, B/PWD orCWD, B/Color/PWD or CWD,B/Power/PWD.Harmonic, Coded Pulse, Realtime 3D& Multi-plane.	✓	✓
Transducers
• M5Sc-D	✓	✓
• 6S-D	✓	✓
• 12S-D	✓	✓
• 6VT-D	✓	✓
• 6Tc-RS/6Tc	✓(K121063)	✓
• 9L-D	✓	✓
• C1-6-D	✓(same transduceras that on thepredicate LOGIQE9 K123564)	✓
• P2D	✓	✓
• 4V-D		✓
• ML6-15-D		✓
• i13L		✓
• 4C-D		✓
• 11L-D		✓
• M4S-D		✓
• M5S-D		✓
• 3V-D		✓
• E8C-D		✓
• 9T		✓
• P6D		✓
• 8C		✓
• iC5-9-D		✓
• C1-5-D		✓
• C2-9-D		✓

{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 font inside. The letters are white and have a swirling design. The logo is simple and recognizable, and it is associated with a well-known company.

Processing &Display features:
Image mapping (color & gray), Time/ spatial filtering and enhancement, TGC, TVI, SI/SRI, TSI, Harmonic Imaging, Pulsatile-Flow, B-Flow, Extended FOV, Tissue Tracking, Realtime 3D and Multi-plane processing, 2D Stress, Blood Flow Imaging (BFI), Spatial Compounding / Speckle Reduction imaging, Slice View, LaserLines, Continuous Tissue Optimization (CTO), Realtime 3D Color Flow, Automated Functional Imaging (AFI w/ Bull's Eye display), LCD display, StereoVision	✓	✓
Multiplane Stress, 4D Stress, TSI w/ surface rendering, Triplane AFI		✓
AFI Stress, Smart Depth	✓(same features as that on the predicate Vivid S5/S6 K121063)
Tested to meet Electrical Safety, EMC and Biocompatibility Standards	✓	✓
Track 3 (within FDA limits)	✓	✓

Summary of Non-Clinical Tests:

The device 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 conform with applicable medical device safety standards. The Vivid S60/S70 and its applications comply with voluntary standards:

1. AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
1. IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety – Collateral

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

510(k) Premarket Notification Submission

Standard: Electromagnetic Compatibility Requirements and Tests

1. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
1. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
1. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
1. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
1. ISO14971, Application of risk management to medical devices
1. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

Risk Analysis
Requirements Reviews ●
Design Reviews ●
Testing on unit level (Module verification) ●
Integration testing (System verification)
Final Acceptance Testing (Validation)
Performance testing (Verification)
Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid S60/S70, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Vivid S60/S70 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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.