The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Device Description

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 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

The provided text is a 510(k) Summary and related Indications for Use forms for the GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound systems. It describes the device, its intended uses, and claims substantial equivalence to a predicate device.

Key takeaway: This documentation explicitly states, "Clinical Tests: None required." Therefore, there are no specific acceptance criteria or a study provided to prove the device meets performance criteria beyond safety and effectiveness compared to a predicate device. The information requested regarding performance metrics, sample sizes, expert qualifications, ground truth, and MRMC studies is not available in these documents because clinical studies were not performed for this 510(k) submission.

However, I can extract the information that is present concerning the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As per the "Non-clinical Tests" section (Section b.1), the device was evaluated for its conformity with applicable medical device safety standards.
The core acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374).

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness Equivalence to Predicate Device	The modified Compact Ultrasound devices are "virtually identical having the same design, construction, materials, brand names and intended uses. All technological characteristics and safety and effectiveness features are equivalent." The device conforms to applicable medical device safety standards.
Acoustic Output	Conforms with applicable medical device safety standards.
Biocompatibility	Conforms with applicable medical device safety standards.
Cleaning and Disinfection Effectiveness	Conforms with applicable medical device safety standards.
Electromagnetic Compatibility	Conforms with applicable medical device safety standards.
Thermal, Electrical, and Mechanical Safety	Conforms with applicable medical device safety standards.
Quality Systems Compliance	Design and development process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. Compliance verified through independent evaluation with ongoing factory surveillance.

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

No clinical test set was used. The submission explicitly states: "Clinical Tests: None required." This is a regulatory filing asserting substantial equivalence based on technical characteristics and safety standards, not a performance study using patient data.

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

Not applicable. As no clinical test set was used, no experts were required to establish ground truth for a test set.

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

Not applicable. No clinical test set and thus no adjudication method were used.

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 MRMC study was done. This device is an ultrasound imaging system, and the submission does not mention any AI components or features that would warrant an MRMC study comparing human reader performance with and without AI assistance.

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

Not applicable. This device is an ultrasound imaging system, not an algorithm being tested in a standalone fashion.

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

Not applicable. No clinical studies requiring ground truth were performed for this submission. The basis for clearance is substantial equivalence to a predicate device and compliance with safety standards.

8. The sample size for the training set

Not applicable. No clinical training set was used as no new algorithm requiring such a set was part of this 510(k) submission.

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

Not applicable. As there was no clinical training set, no ground truth needed to be established for it.

Summary

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OCT 5 2010

142

Attachment B

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

GE Healthcare GE Medical Systems (China) Co., Ltd No. 19 Changjiang Road, National Hi-Tech Development Zone Wuxi, Jiangsu Province, CHINA 214028 Section a): 1. Submitter: GE Medical Systems (China) Co., Ltd. No. 19 Changjiang Road, National Hi-Tech Development Zone, Wuxi, Jiangsu Province, CHINA 214028 Contact Person: Yalan Wu, Manager, Safety and Regulatory Telephone: 86-510-85278652; Fax: 86-510-85227347 Date Prepared: June 20, 2010 2. Device Name: GE LOGIQ ille, Vivid e Ultrasound Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374 (90-IYO/IYN/ITX) A device currently in commercial distribution.

Device Description: The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 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.
Indications for Use: The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Companison with Predicate Device: The modified Compact Ultrasound devices are virually identical having the same design, construction, materials, brand names and intended uses. All technological characteristics and safety and effectiveness features are equivalent. The modified device has additional Transesophageal indication for use and Intima Media Thickness (IMT) measurement with Vascular.

Section b):

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

1. Clinical Tests: None required.

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 9001:2000 and ISO 13485 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 GE LOGIQ ile Vivid e Ultrasound imaging device 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 2510 Street NW BUFFALO MN 55313

OCT 5 2010

Re: K102256

Trade/Device Name: GE LOGIQ i, LOGIQ e and Vivid e Diagnostic Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 27, 2010 Received: September 28, 2010

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 GE LOGIQ i, LOGIQ e and Vivid e Diagnostic Ultrasound, as described in your premarket notification:

	Transducer Model Number
4C-RS	12L-RS	6S-RS
8C-S	16L-RS	P2D
E8C-RS	i12L-RS	6Tc-RS
8L-RS	i/t739-RS
9L-RS	3S-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 Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Mach. A.D.O. Then for

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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Indications for Use Form

510(k) Number (if known):

Device Name: __GE LOGIQ i, LOGIQ e and Vivid e Diagnostic Ultrasound

Indications For Use:

The LOGIQ ile & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OG; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of In Vitro Diagnostics

MuhaMD.D.M. David 6, Brown
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102056

Page 1 of 1

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GE Compact Ultrasound System

LOGIQ i, LOGIQ e, Vivid e

Intended Use: Diagnostic ultrasound imaging or fluid flow 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 / 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]	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
Thoracic/Pleural (specify)[4]	P	P	P	P	P	P	P	P	P	P	P
Other [5]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N	N
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

{4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

["] Coded Pulse is for digitally encoded harmonics.

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Nuhal D. O'Kee for David C. Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

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

GE Compact Ultrasound with 4C-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	P
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]	P	P	P		P		P	P	P	P
Other[5]	P	P	P		P		P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

["] Coded Pulse is for digitally encoded harmonics.

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Mudand D. O'K. Go. David b. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

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

GE Compact Ultrasound with 8C-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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[1]	P	P	P		P		P	P	P
Pediatric	P	P	P		P		P	P	P
Small Organ [2]	P	P	P		P		P	P	P
Neonatal Cephalic	P	P	P		P		P	P	P
Adult Cephalic
Cardiac [3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]	P	P	P		P		P	P	P
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

(*) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.

] Coded Pulse is for digitally encoded harmonics .

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Mhll.D.O'K. for David C. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and S

510(k) K102256

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

GE Compact Ultrasound with E8C-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

		Mode of Operation
Clinical ApplicationAnatomy/ Region of interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P
Abdominal[1]	P	P	P		P		P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other[5]	P	P	P		P		P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P	P
Transvaginal	P	P	P		P		P	P	P
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

[*] Coded Pulse is for digitally encoded harmonics .

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Andrew D. Kirk for David G. Brown
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with 8L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ [2]	P	P	P		P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P		P		P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

[1] Coded Pulse is for digitally encoded harmonics.

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Andrew D. Thoms for David C. Brown
Division Sign Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

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

GE Compact Ultrasound with 9L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

Mode of Operation Clinical Application PW CW Color Color M B Power Combined M Harmonic Coded Other Anatomy/Region of Interest Doppler Doppler Doppler Doppler Doppler Modes lmaging Pulse® Ophthalmic Fetal / Obstetrics Abdominal [1] P P P P P P P P Pediatric P P P P P P P P Small Organ 같 P P P P P P P P Neonatal Cephalic Adult Cephalic Cardiac (3) Peripheral Vascular P P P P P P P P Musculo-skeletal Conventional P P P P P P P P Musculo-skeletal Superficial Thoracic/Pleural (specify) [4] Other (5) Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative (specify)[5] P P P P P P P P Intraoperative Neurological Intravascular Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

*] Coded Pulse is for digitally encoded harmonics .

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Michal D. O'Shea Lisa David G. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

ce of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with 12L-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P
Thoracic/Pleural (specify) [4]	P	P	P	P	P	P	P	P
Other (specify) [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative [5] (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

(*) Coded Pulse is for digitally encoded harmonics.

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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Andra D'Oliveira for David 6 Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

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

GE Compact Ultrasound with 16L-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

Mode of Operation Clinical Application bM CM B Color Power Combined Color M M Harmonic Coded Anatomy/Region of Interest Doppler Doppler Doppler Doppler Modes Doppler Imaging Pulse® Ophthalmic Fetal / Obstetrics Abdominal Pediatric P P P p P P P P Small Organ 121 P P P P P P P P Neonatal Cephalic Adult Cephalic Cardiac Peripheral Vascular P P P P P P P P Musculo-skeletal Conventional P P P P P P P P Musculo-skeletal Superficial P P P P P P P P Thoracic/Pleural (specify) [4] Other (specify) 15) Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transuretheral Intraoperative [3] (specify) Intraoperative Neurological Intravascular Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

["] Coded Pulse is for digitally encoded harmonics.

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Aayyad Dothan Lan David 6. Boiso
Division Sign Off

office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with i12L-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	P		P		P	P	P	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ [2]	P	P	P		P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P
Thoracic/Pleural (specify) [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P		P		P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

{4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

[1] Coded Pulse is for digitally encoded harmonics .

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

nce of CDRH, Office of In Vitro Diagnostics (OIVD)

Auhul 1052K for David b Brown
Division Sign-Off

fice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with i/t739-RS Transducers

LOGIQ i, LOGIQ e, Vivid e

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P
Pediatric	P	P	P		P		P	P	P
Small Organ [2]	P	P	P		P		P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) (4)
Other (4)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P		P		P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

["] Coded Pulse is for digitally encoded harmonics.

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Ardd DDK for David b. Brown
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with 3S-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*
Ophthalmic
Fetal / Obstetrics	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 [2]
Neonatal Cephalic
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
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify)[4]	P	P	P	P	P	P	P	P	P	P
Other [5]	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

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

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

[*] Coded Pulse is for digitally encoded harmonics .

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Nuhad D. Khawam for David 6. Brown
Division Sign-Off

Prescription Use (21 CFR 801 Subpart D)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102256

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

GE Compact Ultrasound with 6S-RS Transducer

LOGIQ İ, LOGIQ e, Vivid e

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	CodedPulse¹	Other
Ophthalmic
Fetal / Obstetrics
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	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
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]	P	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

["] Coded Pulse is for digitally encoded harmonics .

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Ahaland D. K. for David G. Brown
Division Sign Off

510(k) K102256

Office of In Vitro Diagnostic Device Evaluation and Safety

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

GE Compact Ultrasound with P2D Transducer

LOGIQ i, LOGIQ e, Vivid e

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[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) [4]
Other [5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

] Coded Pulse is for digitally encoded harmonics .

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Andrew D. Klee for David 6 Brown
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K102256

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

GE Compact Ultrasound with 6Tc-RS Transducer

LOGIQ i, LOGIQ e, Vivid e

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(1)
Pediatric
Small Organ (2)
Neonatal Cephalic
Adult Cephalic
Cardiac (3)	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular									N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural (specify) (4)
Other [5]
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify) [5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN and Urological

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

[3] Cardiac is Adult and Pediatric.

[4] For detection of fluid and pleural motion/sliding;

[5] Other use includes Urology/Prostate

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

[*] Coded Pulse is for digitally encoded harmonics .

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

ha D.M. for David 6. Browns
Division Sign Off

510(k) K102556

Office of In Vitro Diagnostic Device Evaluation and Safety

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.