The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Device Description

The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the GE Vivid S5/S6 Diagnostic Ultrasound System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary) for the GE Vivid S5/S6 is a premarket notification for a modification to an already legally marketed device. It does not present specific quantitative acceptance criteria or detailed performance metrics in the typical sense of a clinical or analytical performance study. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to its predicate device (Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K092079).

The reported device performance is that it meets this substantial equivalence:

Acceptance Criteria (Implied)	Reported Device Performance
Comparable type to predicate device	The modified Vivid S5/S6 is of a comparable type to the current Vivid S5/S6.
Substantially equivalent to predicate device	The modified Vivid S5/S6 is substantially equivalent to the current Vivid S5/S6, having the same overall characteristics, key safety and effectiveness features, physical design, construction, materials, and intended uses and operating modes. It also has additional software features similar to other cleared GE Ultrasound systems.
Conforms with applicable medical device safety standards	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. Compliance is verified through independent evaluation with ongoing factory surveillance.
Complies with voluntary standards	The modified Vivid S5/S6 and its applications comply with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission.
Risk analysis conducted	Risk analysis conducted.
Requirements Reviews conducted	Requirements Reviews conducted.
Design Reviews conducted	Design Reviews conducted.
Testing on unit level (Module verification)	Testing on unit level (Module verification) conducted.
Integration testing (System verification)	Integration testing (System verification) conducted.
Final Acceptance Testing (Validation)	Final Acceptance Testing (Validation) conducted.
Performance testing (Verification)	Performance testing (Verification) conducted.
Safety testing (Verification)	Safety testing (Verification) conducted.
Transducer and patient contact materials are biocompatible	Transducer materials and other patient contact materials are biocompatible.
Intended uses and key features consistent with clinical practice, FDA guidelines, and established methods	Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.
Design and development process conforms with 21 CFR 820 and ISO13485 quality systems	The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence."

Therefore, there is no separate "test set" in the context of clinical performance evaluation described here. The evaluation relies on non-clinical tests (acoustic output, biocompatibility, safety, etc.) and comparison to the predicate device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable, as no clinical studies requiring expert-established ground truth were performed for this specific submission to demonstrate substantial equivalence.

4. Adjudication Method

Not applicable, as no clinical studies requiring adjudication were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence based on technical specifications and non-clinical testing, not on improved human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is an ultrasound system, not an AI algorithm intended for standalone performance evaluation in the context of this 510(k) submission. The document mentions "additional software features that are similar to other cleared GE Ultrasound systems," but does not detail any standalone performance studies for these features.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device relies on:

Compliance with established safety and performance standards: Non-clinical tests (acoustic output, biocompatibility, electrical, thermal, mechanical safety).
Comparison to predicate device specifications and performance: The existing cleared Vivid S5/S6 (K092079) serves as the benchmark for "truth" in terms of equivalence.

8. Sample Size for the Training Set

Not applicable, as this submission is for an ultrasound system based on established technology and substantial equivalence, not a new AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of an AI model training set in this submission.

Summary

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NOV - 5 2010 K102393

Section 5 — 510(k) Summary

Vivid S5/S6

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510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System August 18, 2010

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	18 August 2010
Submitter:	GE Healthcare [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE Healthcare, [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]T:(414)721-4214F:(414)918-8275GE Healthcare
Secondary Contact Person:	Jim TurnerRegulatory Affairs Manager America's ServiceGE Healthcare, [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]T:(262) 544-3359F:(414)908-9225
Device: Trade Name:	Vivid S5 and Vivid S6 Diagnostic Ultrasound System
Common/Usual Name:	Vivid S5, Vivid S6
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K092079currently in commercial distribution.
Device Description:	The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wideassortment of electronic array transducers intended primarily for echocar-diography with additional capability in vascular and general ultrasoundimaging. Its intuitive user interface, high level of auto-optimization alongwith significantly reduced size and weight make it readily maneuverable,efficient and easy to use.
Intended Use:	The device is intended for use by a qualified physician for ultrasoundevaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric;Small Organ (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular; Mus-culo-skeletal Conventional and Superficial; Urology (including pros-tate); Transesophageal; Transrectal; Transvaginal; and Intraoperative(abdominal, thoracic, and vascular).

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and appear to be in a cursive font. The logo is black and white.

Technology: The modified Vivid S5/S6 employs the same fundamental scientific technology as its predicate devices.

Comparison with the predicate device shows the modified Vivid S5/ S6 is of a comparable type and substantially equivalent to the current Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device. The modified Vivid S5/S6 has additional software features that are similar to other cleared GE Ultrasound systems. Summary of Non-Clinical Tests:

Determination of Substantial Equivalence:

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 modified Vivid S5/S6 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were 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, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are decorative swirls or flourishes around the outer edge of the circle.

GE Healthcare considers the modified Vivid S5/S6 to be as safe, and Conclusion: effective as the predicate device(s). The performance of the modified Vivid S5/S6 is substantially equivalent to the predicate device(s).

Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the Vivid S5/S6 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

NOV - 5 2010

Re: K102393

Trade/Device Name: Vivid S5 and Vivid S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II . Product Code: IYN, IYO, and ITX Dated: October 4, 2010 Received: October 5, 2010

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Vivid S5 and Vivid S6 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

6Tc/6Tc-RS 6T/6T-RS 9T/9T-RS 6T-RS

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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1102393

NOV - 5 2010

510(k) Number (if known):

Device Name: Vivid S5/S6

Indications for Use:

The current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Prescription Use___X_ (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K102393

Page 1 of 1

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Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 Diagnostic Ultrasound System

Intended Use: Ultrasound imaging, measurement and 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
Ophthalmic	P	P	P	P	P	P	P	P	P	P	P
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 (specify)[2]	P	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
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	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA on Vivid S5/S6 (K071985); E = added under Appendix E

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.
[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

(Division Sign-Off)

Cardiac is Adult and Pediatric.
Other use includes Urology.

[4] Other use includes Urology.

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M

[+] Coded Pulse is for digitally encoded harmonics ..

[♥] Coded Pulse is for digitally encoded harmonics..

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510K

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Confidential and Privileged. This document confidential and privileged trade secrets and other information of Creters Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the border of the circle are white, while the background inside the circle is black.

(Division Sign-Off) Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510k

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 6Tc/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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac(3)	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)
Exam Type, Means ofAccess
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
IntraoperativeNeurological
Intravascular
Laparoscopic

P = previously cleared by FDA; (Transducer previously cleared on Vivid S5/S6 (K092079));

E = added under Appendix E

Notes:

[3] Cardiac is Adult and Pediatric.

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

[+] Coded Pulse is for digitally encoded harmonics.

[**] 6Tc-RS is cleared on Vivid S5/S6 BT10 (K092079). 6Tc differs from 6Tc-RS only in the connector type

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Confidential and Privileged. This document confidential and privileged trade secrets and other information of General Elective Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.

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Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 6T/ 6T-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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means ofAccess
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify) [5]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (Transducer previously cleared on Vivid $6 (167 1985);

E = added under Appendix E

Notes:

(Division Sign-Off)
Division of Radiological Devices

[3] Cardiac is Adult and Pediatric. *) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

· ] Coded Pulse is for digitally encoded harmonics.

*] Due to a Typo, probe 6T was not listed in this form's heading in K071985. The probets mich

S5/S6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Confidential and Privileged. This document contidential and privileged rode secrets and other information of Ceneral Elective Co. and or such may not be disclosed to others not employed by General Electric Co. All rights reserved.

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.

GE Healthcare 510(k) Premarket Notification Submission Vivid S5/S6 Ultrasound System August 18, 2010

Diagnostic Ultrasound Indications for Use Form

GE Vivid S5/S6 with 9T/ 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
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-skeletalConventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means ofAccess
Transesophageal	P	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

E = added under Appendix E

Notes:

(Division Sign-Off)
ision of Radiological Devices
Diagnostic Devices Branch

[3] Cardiac is Adult and Pediatric.

ተ. ነው። የጥንተ፡ንጥ Diagnostic Device Evaluation and Safety [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[�] Coded Pulse is for digitally encoded harmonics.

[**] Due to a Typo, probe 6T was not listed in this form's heading in K071985. The probe is included in. $5/$6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Confidential and Privileged. This document contidential and privileged rede secrets and other information of General Elective Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved.

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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 black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form

Vivid S5/S6 -with 6T-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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means ofAccess
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transurethral
Intraoperative (specify)[5]
IntraoperativeNeurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA, (Transducer previously cleared on Vivid S5/26 (K071985); E = added under Appendix E

Notes:

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

[3] Cardiac is Adult and Pediatric. [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M

[+]Coded Pulse is for digitally encoded harmonics.

(4) Coded Pulse is for digitaly encoded harmonics.
[** Due to a Type, probe 9T was not listed in this form's heading in K071985. The probee in viving S5/S6 K071985 (see Table 2.3.3 - Transducer Characteristics Summary and Special Report)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Confidential and Privileged. This cocument continential and privileged trade secrets and other information of Centre Co. and us such may not be disclosed to others not employed by General Electric Co. All rights reserved.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.