Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System

• K Number: K142323
• Device Name: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
• Manufacturer: GE MEDICAL SYSTEMS ISRAEL LTD.
• Date Cleared: 2014-10-10 ( 51 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

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.

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard diagnostic ultrasound system and does not mention AI, ML, or any related technologies in the device description or intended use. While it mentions image processing, this is a common feature of ultrasound systems and does not necessarily indicate AI/ML.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," which indicates it is used for diagnosis, not therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "The Vivid S60/S70 is a Track 3 diagnostic ultrasound system," and the "Predicate Device(s)" list several "Diagnostic Ultrasound System" devices.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console, electronic array transducers, a user control panel, and displays, indicating it is a hardware-based ultrasound system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly describes the device as being used for ultrasound evaluation of various anatomical sites and patient populations. This involves using sound waves to create images of internal structures.
• Device Description: The description details a diagnostic ultrasound system with transducers, a console, and displays. This aligns with the technology used for medical imaging, not for testing samples outside the body.
• Input Imaging Modality: The input modality is explicitly stated as Ultrasound. IVD devices typically use modalities like chemical analysis, immunoassay, or molecular diagnostics to analyze biological samples.
• Lack of Mention of Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a core function of IVD devices.

IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This ultrasound system is used for imaging the body directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophageal.

Indicated Patient Age Range

Adult and pediatrics

Intended User / Care Setting

Qualified physician; Not specified but presumed clinical setting (e.g., hospital, clinic) based on device type.

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

Not Found

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

Not Found

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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

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Indications for Use Forms

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

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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 Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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.

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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 Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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

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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 Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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);

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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
Clinical
Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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);

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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 Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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);

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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 Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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);

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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 Application
Anatomy/ Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | RT3D
Mode* |
|-----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| 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.

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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 Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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

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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
Clinical
Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
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);

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510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	August 18, 2014
Submitter:	GE Healthcare
9900 Innovation Dr
Wauwatosa, WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Manager
GE Healthcare
T:[phone]
F:[phone]
Alternate Contact Person:	Karin Shimoni
Regulatory Affairs Leader
GE Healthcare
T: [phone]
F: [phone]
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-IYO
Diagnostic 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 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.

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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 Device
Vivid S60/S70 | Predicate Device
Vivid E9 (K131514) |
|-----------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------|
| Indications and Clinical Applications: | | |
| • Fetal/Obstetrics; | ✓ | ✓ |
| • Abdominal (Including
Renal & Gyn) | ✓ | ✓ |
| • Pediatric | ✓ | ✓ |
| • Small Organ (breast, testes,
thyroid); | ✓ | ✓ |
| • Neonatal Cephalic; | ✓ | ✓ |
| • Adult Cephalic; | ✓ | ✓ |
| • Cardiac (adult and
pediatrics); | ✓ | ✓ |
| • Peripheral Vascular; | ✓ | ✓ |
| • Musculo-skeletal
Conventional | ✓ | ✓ |
| • Urology (including
prostate); | ✓ | ✓ |
| • Transesophageal; | ✓ | ✓ |
| • Transrectal (TR); | | ✓ |
| • Transvaginal (TV); | | ✓ |
| • Intraoperative (abdominal,
thoracic, & vascular). | | ✓ |
| Probe Array: | | |
| Phased Array, Matrix Single Crystal
Phased Array Probe, Linear, Curved,
pencil (Doppler), Transesophageal | ✓ | ✓ |

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Image modes:
B, M, Color M, Color/Power Doppler,
Pulsed & CW Doppler, Combined
modes: B/M, B/Color M, B/PWD or
CWD, 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 transducer
as that on the
predicate LOGIQ
E9 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		✓

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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
• 2. 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

• 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• 4. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
• 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• 7. ISO14971, Application of risk management to medical devices
• 8. 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.