The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB: 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, Transrectal and Transvaginal.

Device Description

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ-i, LOGIQ-e and Vivid-e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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 Special 510(k) Premarket Notification for the GE LOGIQ-i/e & Vivid-e Compact Ultrasound system explicitly states that no clinical tests were required for this submission. The rationale given is: "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

Therefore, the document does not contain acceptance criteria in the context of clinical performance metrics (like sensitivity, specificity, accuracy) derived from a study validating the device's diagnostic capabilities, nor does it describe a study to prove those criteria are met. The acceptance criteria and "reported device performance" in this context relate to demonstrating substantial equivalence to a predicate device through non-clinical testing and verification of intended use without introducing new safety or effectiveness concerns.

Here's a breakdown of the requested information based on the provided text, while acknowledging the absence of clinical performance data:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical outcome-based acceptance criteria are presented or met via clinical study, the acceptance criteria here are derived from the regulatory requirements for establishing substantial equivalence for an ultrasound device.

Acceptance Criteria (Non-Clinical/Regulatory)	Reported Device Performance
Device Description & Intended Use Equivalence: The modified device is "virtually identical having the same design, construction, materials, brand names and intended uses" as the predicate device (K050126), with additional transducers, enhanced imaging (for invasive needles), and electrical docking carts. It must maintain traditional clinical practice, FDA guidelines, and established methods of patient examination.	The device, including all listed transducers (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D), successfully indicated its intended use for various clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Transrectal, Transvaginal, Intra-operative) across multiple modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse), where applicable. The expanded indications (marked "E") and new harmonics ("N") for specific transducers were deemed equivalent based on this submission.
Safety Standards Conformance: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety. Compliance with applicable medical device safety standards.	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." Compliance is "verified through independent evaluation by a Nationally Recognized Testing Lab. (NRTL) with ongoing factory surveillance."
Quality Systems Conformance: Design and development process conforms with 21 CFR 820, ISO 9001, and 13485 quality systems.	The "design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and 13485 quality systems."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. No clinical test set.
Data Provenance: Not applicable. No clinical data was used for testing against acceptance criteria in this submission. The submission relies on non-clinical evaluations and the substantial equivalence to a previously cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established for a test set. The determination of "substantial equivalence" was a regulatory decision based on documented non-clinical tests and comparison to a predicate device.

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

Not applicable. No clinical test set requiring adjudication was performed.

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 comparative effectiveness study was done. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. This submission is for a diagnostic ultrasound system.

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

Not applicable. No clinical ground truth was used. The basis for clearance was a demonstration of substantial equivalence to a predicate device through non-clinical testing and design documentation.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

Summary

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

Special 510(k) Premarket Notification GE LOGIQ-i/e & Vivid-e Compact Ultrasound September 28, 2007

K072797

OCT 17 2007

Attachment B:

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

	GE Healthcare
	General Electric CompanyP.O. Box 414, Milwaukee, WI 53201

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Ultrasound Regulatory AffairsTelephone: 414-721-3992; Fax: 414-721-3899
Date Prepared:	September 25, 2007
2. Device Name:	GE LOGIQ-i/e & Vivid-e Compact UltrasoundUltrasonic 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

Marketed Device: GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K050126.
Device Description: The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ-i, LOGIQ-e and Vivid-e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array 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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB: 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, Transrectal and Transvaginal.
Comparison with 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 effectiveness features are equivalent. The modified device has additional transducers, enhanced imaging to better visualize invasive needles and electrical docking carts for greater flexibility and ease of use.

Section b):

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.
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 and 13485 guality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation by a Nationally Recognized Testing Lab. (NRTL) 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 Compact Ultrasound is substantially equivalent with respect to safely and effectiveness to diagnostic ultrasound 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble a human figure or a stylized wave pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2007

Mr. Allen Schuh Manager, Regulatory Affairs GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226 USA

Re: K072797

Trade/Device Name: GE LOGIQ-i/e & Vivid-e Compact Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 28, 2007 Received: October 1, 2007

Dear Mr. Schuh:

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/e & Vivid-e Compact Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C-RS	i12L-RS
8C-RS	i/t739-RS
E8C-RS	3S-RS
8L-RS	6S-RS
9L-RS	P2D
12L-RS

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

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 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 (OS) 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 report 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 (240) 276-0120. 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) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

Dovê thi nhung

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

Enclosure(s)

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

Special 510(k) Premarket Notification GE LOGIQ-i/e & Vivid-e Compact Ultrasound September 28, 2007

Diagnostic Ultrasound Indications for Use Form

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:

	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	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]	P	P	P	P	P	P	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	E	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal Superficial
Other[4]	P	P	P	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	P	P	P		P		P	P	P	E
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aran M. Whay
(Division Sign-Off)

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

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

Special 510(k) Premarket Notification GE LOGIQ-ile & Vivid-e Compact Ultrasound September 28, 2007

Diagnostic Ultrasound Indications for Use Form

GE Compact Ultrasound with 4C-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	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 (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P		P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN;

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology;

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

[*] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

loure M. Whan

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

Prescription User (Per 21 CFR 801.109)

{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:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P
Small Organ (specify)	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
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[3] Cardiac is Adult and Pediatric.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lozue M. Whay

(DIAKS oductive, Abdominal a Division of Radiological Devices 510(k) Number

Prescription User (Per 21 CFR 801.109)

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

GE Compact Ultrasound with E8C-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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	N
Abdominal [1]	P	P	P		P		P	P	N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	P	P	P		P		P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P	N
Transvaginal	P	P	P		P		P	P	N
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/Pelvic;

[4] Other use includes Urology/Prostate;

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

Loyu Th-Whag

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

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

GE Compact Ultrasound with 8L-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	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ (specify)[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
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

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

[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 is for digitally encoded harmonics and B-flow.

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

Loyu Tn Whang

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

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

GE Compact Ultrasound with 9L-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	Mode of Operation
	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E		E		E	E	E	E
Pediatric	E	E	E		E		E	E	E	E
Small Organ (specify)[2]	E	E	E		E		E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E		E		E	E	E	E
Musculo-skeletal Conventional	E	E	E		E		E	E	E	E
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	E	E	E		E		E	E	E	E
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic,

[3] Cardiac is Adult and Pediatric.

[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 is for digitally encoded harmonics and B-flow.

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

loyne M Whay

Division of Reproductive. Abd Radiological Devices 510(k) Number

{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:

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	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
Other (specify)
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: [2] Small organ includes breast, testes, thyroid.

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

[*] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Lorry M. Whig

(Divisio ductive. Abdom Division of Re Radiological Devices 510(k) Number

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

GE Compact Ultrasound with i12L-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	Mode of Operation
	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 (specify)[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
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

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

Notes: [1] Abdominal includes GYN.

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

[3] Cardiac is Adult and Pediatric.

[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 is for digitally encoded harmonics and B-flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aryu M. Why

Radiolog 510(k) Numbe

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

GE Compact Ultrasound with i/t739-RS Transducers

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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P
Small Organ (specify)[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
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

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

Notes: [3] Cardiac is Adult and Pediatric via intraoperative.

[5] 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)

lory m Wh

Prescription User (Per 21 CFRivision of Reproductive, Abd Radiolog 510(k) Nun

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

GE Compact Ultrasound with 3S-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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse*	Other
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 (specify)
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
Other[4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[3] Cardiac is Adult and Pediatric.

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

[1] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Aorue M. Whay

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

E-11

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

GE Compact Ultrasound with 6S-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]	E	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E	E
Small Organ (specify)[2]
Neonatal Cephalic	E	E	E	E	E	E	E	E	E	E
Adult Cephalic	E	E	E	E	E	E	E	E	E	E
Cardiac [3]	E	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]	E	E	E	E	E	E	E	E	E	E
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

[*] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Lonne In Whaz

Reproductive, Abdom Radiological Devices 510(k) Number

Prescription User (Per 21 CFR 801.109)

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

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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]				E
Peripheral Vascular				E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
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.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

[*] Coded Pulse is for digitally encoded harmonics and B-flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aoguth Whay

Radiologic 510(k) Number

E-13

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.