VIVID I AND VIVID Q

• K Number: K082374
• Device Name: VIVID I AND VIVID Q
• Manufacturer: GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
• Date Cleared: 2008-09-02 ( 15 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K051449 , K033139 , K072797 , K033650 , K061525
• Predicate For: K092140

Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; 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; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

Device Description

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

AI/ML Overview

Here's an analysis of the provided text regarding the GE Vivid-i and Vivid-q Diagnostic Ultrasound System.

Acceptance Criteria and Study for GE Vivid-i and Vivid-q Diagnostic Ultrasound System (K082374)

Based on the provided document, the GE Vivid-i and Vivid-q Diagnostic Ultrasound System's acceptance criteria and proof of their being met are primarily based on substantial equivalence to a predicate device and compliance with recognized safety and quality standards, rather than a clinical performance study with specific quantitative acceptance criteria or statistical measures of device performance.

The document states: "The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems."

And under "Conclusion": "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, ISO 9001 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 Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

Furthermore, it explicitly states under "Clinical Tests: None required."

Therefore, the "acceptance criteria" here are framed around demonstrating equivalence to existing, legally marketed devices and adherence to established regulatory and engineering standards.

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1. Table of Acceptance Criteria and Reported Device Performance

Given that no specific quantitative performance metrics from a clinical study are reported, the table reflects the qualitative acceptance criteria related to substantial equivalence and safety/quality standards.

Acceptance Criterion (Qualitative)	Reported Device Performance
Substantial Equivalence to Predicate Device	The GE Vivid-i and Vivid-q is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i (K061525). It has the same design, construction, and materials, and comparable key safety and effectiveness features. Its intended uses are identical to the predicate device, and additional software features are identical to other cleared GE Ultrasound systems.
Compliance with Safety Standards (Non-clinical)	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety. It has been found to conform with applicable medical device safety standards. Compliance is verified through independent evaluation with ongoing factory surveillance.
Quality System Compliance	The design and development process conforms with 21 CFR 820, ISO 9001, and ISO13485 quality systems.
Consistency with Clinical Practice & FDA Guidelines	Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. Diagnostic ultrasound has a long history of safe and effective performance. The device is intended for use by a qualified physician for a wide range of ultrasound evaluations (Fetal; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology; Transesophageal; Transvaginal; Intraoperative; Intra-cardiac; and Intra-luminal). Specific transducers (M4S-RS, 3C-RS, 3S-RS, 9T-RS, 4C-RS, 8C-RS, 7S-RS, P2D, 12L-RS, 8L-RS, 10S-RS, P6D, 5S-RS, i12L-RS, 6T/6Tc-RS, 6S-RS, AcuNav™ 10F) are listed with their specific clinical application clearances (P=previously cleared, N=new indication, E=added under Appendix E).
Post-market Requirements	A post-clearance special report is required prior to shipping the first device, containing complete information including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."

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

• Sample Size for the Test Set: Not applicable. No clinical test set or study validating specific performance metrics (like sensitivity/specificity) was conducted. The clearance is based on substantial equivalence to a predicate device and adherence to manufacturing and safety standards.
• Data Provenance: Not applicable for a performance test set. The predicate device (GE Vivid-i Ultrasound System, K061525) and other cleared GE Ultrasound systems provide the basis for equivalence.

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

• Not applicable. No new clinical trials or studies requiring ground truth establishment by experts for specific diagnostic performance were conducted for this 510(k) submission. The safety and effectiveness are inferred from the predicate device and the known history of diagnostic ultrasound.

4. Adjudication method for the test set

• Not applicable. No performance test set requiring adjudication was conducted.

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

• No. This submission does not involve AI. The device is a diagnostic ultrasound system.

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

• No. This submission does not involve an algorithm. The device is a diagnostic ultrasound system.

7. The type of ground truth used

• Not applicable. No new clinical performance data requiring ground truth was generated. The approval relies on the established safety and effectiveness of the predicate device and the general class of diagnostic ultrasound systems.

8. The sample size for the training set

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

Summary

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Y082374

SEP - 2 2008

Section 2 Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, contrasting with the white background.

2

GE Healthcare

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

Submitter:	GE Medical Systems Israel, Ultrasound LTDHaetgar Str. 4Tirat Carmel, ISRAEL 39120
Contact Person:	Israel Citron,Quality Assurance and Regulatory Affairs managerTelephone: 972-4-8519-555; Fax: [phone]
Date Prepared:	July 31, 2008

Device Name:	GE Vivid-i and Vivid q Diagnostic Ultrasound SystemUltrasonic 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
--------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3. Marketed Device: GE Vivid-i Ultrasound System, K061525 currently in commercial distribution.

4. Device Description: The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; 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; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

6. Comparison with Predicate Device: The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems.

Section b):

1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

3. Oncelusion: 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, ISO 9001 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 Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems, Ultrasound % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

SEP - 2 2008

Re: K082374

Trade/Device Name: Vivid - i and Vivid - q Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: August 15, 2008 Received: August 18, 2008

Dear Mr. Job:

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 - i and Vivid - q, as described in your premarket notification:

Transducer Model Number

Vivid i/q with M4S-RS	Vivid i/q with 3C-RS	Vivid i/q with 3S-RS	Vivid i/q with 9T-RS
Vivid i with 4C-RS	Vivid i/q with 8C-RS	Vivid i/q with 7S-RS	Vivid i/q with P2D
Vivid i with 12L-RS	Vivid i/q with 8L-RS	Vivid i/q with 10S-RS	Vivid i/q with P6D
Vivid i/q with 5S-RS	Vivid i/q with i12L-RS	Vivid i/q with 6T/6Tc-RS	Vivid i/q with 6S-RS
Vivid i/q with AcuNav TM 10F

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 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

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Page 2 - Mr. Mark Job

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special renor is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-201 or (240) 27-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at [phone].

Sincerely yours,

Vorin M. Whay

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Diagnostic Ultrasound Indications for Use Form GE Vivid-i and Vivid-g 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
Fetal	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	E	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	E	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	E	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	E	P	P	P	P
Other[4]	P	P	P	P	P	E	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	N	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal	N	N	N	N	N	N	N	N	N
Laparoscopic

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

Notes: [1] Abdominal includes Renal.

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

• ["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
  {"} Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with M4S-RS Transducer

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal	N	N	N	N	N	N	N	N	N	N
Abdominal [1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac [2]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular									N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

Intended Use: Ultrasound imaging, measurement and analysis of the human body as foll

N = new indication (transducer previously cleared with Vivid 7 system K051449); P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes Renal

[2] 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.

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CP).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

Aorai In Mitz

(Division Sign Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

{5}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE Vivid-i with 4C-RS Transducer

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

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K061525); E = added under Appendix E

Notes: [1] Abdominal includes Renal;

[2] Other use includes Urology.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

Domi In Wh

(Division Sign-Off) Division of Reproductive and Radiological Dev

510(k) Number

{6}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE Vivid-i with 12L-RS Transducer

Mode of Operation Clinical Application PW CW Color Color M Power Combined Harmonic B M Coded Other Anatomy/Region of Interest Doppler Doppler Doppler Doppler Doppler Modes Imaging Pulse Ophthalmic Fetal Abdominal Pediatric Small Organ(1) P P p P E P P P P Neonatal Cephalic Adult Cephalic Cardiac Peripheral Vascular P P P P P m P P P Musculo-skeletal Conventional P P P P ח P P P P Musculo-skeletal Superficial P P P P E P P P P Other (specify) Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative (specify) Intraoperative Neurological Intracardiac and Intraluminal Laparoscopic

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K061525); E = added under Appendix E

Notes: [1] Small organ includes breast, testes, thyroid.

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

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI),

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid-i/q with 5S-RS Transducer

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P	P
Abdominal
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K061525); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Device 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid-i/q with 3C-RS Transducer

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

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Abdominal includes Renal.

[2] Other use includes Urology.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

forgath why

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Dev 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid-i/q with 8C-RS Transducer

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
Fetal
Abdominal	P	P	P		P	E	P	P	P	P
Pediatric	P	P	P		P	E	P	P	P	P
Small Organ (specify)[1]	P	P	P		P	E	P	P	P	P
Neonatal Cephalic	P	P	P		P	E	P	P	P	P
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	E	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Small organ includes breast, testes, thyroid.

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

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arzu M. Whay

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number .

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 8L-RS Transducer

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
Fetal
Abdominal	P	P	P		P	E	P	P	P	P
Pediatric	P	P	P		P	E	P	P	P	P
Small Organ (specify)[1]	P	P	P		P	E	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	E	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	E	P	P	P	P
Musculo-skeletal Superficial	P	P	P		P	E	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Small organ includes breast, testes, thyroid.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI).

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

---

(Division Sign-Off)

Prescription User (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with i12L-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal
Abdominal	P	P	P		P	E	P	P	P
Pediatric	P	P	P		P	E	P	P	P
Small Organ (specify)[1]	P	P	P		P	E	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	E	P	P	P
Peripheral Vascular	P	P	P		P	E	P	P	P
Musculo-skeletal Conventional	P	P	P		P	E	P	P	P
Musculo-skeletal Superficial	P	P	P		P	E	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[3]	P	P	P		P	E	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Small organ includes breast, testes, thyroid.

[2] Cardiac is Adult and Pediatric.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devices 510(k) Number .

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 3S-RS Transducer

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

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Abdominal includes Renal.

[2] Cardiac is Adult and Pediatric.

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

["] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI),

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Angel McWhay

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 7S-RS Transducer

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
Fetal	E	E	E	E	E	E		E	E
Abdominal	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	E	E	E	E	E	E	E	E	E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arqui M. Why

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 10S-RS Transducer

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

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number.

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 6T/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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P		P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aryal Mr. Wang

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number.

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 9T-RS Transducer

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
Fetal
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P		P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P		P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

Amal M Whaz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number ..

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with P2D Transducer

	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 [1]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Somain Whiz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number.

Prescription User (Per 21 CFR 801.109)

{18}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with P6D Transducer

Mode of Operation Clinical Application PW CW Color Color M Power Combined B M Harmonic Coded Other Anatomy/Region of Interest Doppler Doppler Doppler Doppler Doppler Modes Imaging Pulse Ophthalmic Fetal / Obstetrics Abdominal Pediatric Small Organ (specify) Neonatal Cephalic Adult Cephalic Cardiac (1) P P Peripheral Vascular P P Musculo-skeletal Conventional Musculo-skeletal Superficial Other Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative (specify) Intraoperative Neurological Intracardiac and Intraluminal Laparoscopic

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P = previously cleared by FDA (K033139); E = added under Appendix E

Notes: {1} Cardiac is Adult and Pediatric.

["] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Arzain M. Wiz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with 6S-RS Transducer

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
Fetal	N	N	N	N	N	N	N	N	N	N	N
Abdominal	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 (specify)
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac [1]	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication (transducer previously cleared with LOGIQ-ile and Vivid-e systems K072797); P = previously
cleared by FDA: E = added under Annondiv E cleared by FDA; E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

{*} Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jorgelutz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number_

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

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with AcuNav™ 10F Transducer

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
Fetal
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal	N	N	N	N	N	N	N	N	N
Laparoscopic

N = new indication (transducer previously cleared as a stand alone medical device K033650); P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Cardiac is Adult and Pediatric.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Josefin Wetz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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.