Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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; and Intraoperative (abdominal, thoracic, vascular and neurological).

Device Description

The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system available in Expert (full featured) or Pro (reduced feature) versions consists of a mobile console approximately 52 cm wide. 99 cm deep and 135 cm high that provides digital image acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification adds coded pulse modes from high-end LOGIQ systems to the Expert version and removes provides limited options for the Pro version.

AI/ML Overview

The provided document is a 510(k) premarket notification for the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound System, which was filed in 2003. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study as would be required for novel devices or those with significant changes in indications for use.

Therefore, the document does not contain information related to acceptance criteria or clinical studies designed to prove device performance in the way a modern AI/ML device submission would. Instead, it focuses on demonstrating that the new ultrasound system is as safe and effective as its predicate device.

Here's why the requested information is absent and what the document does provide:

A table of acceptance criteria and the reported device performance: This is not present. The submission is not structured around demonstrating performance against predefined metrics in a clinical trial. The "performance" assessment is based on comparison to the predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a clinical study for performance evaluation is mentioned because no such clinical study was required for this 510(k) submission.
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): No ground truth establishment or expert involvement for performance validation is described, as it was not required for this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no clinical test set for performance validation.
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: Not applicable. This is an ultrasound imaging system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for performance evaluation was established.
The sample size for the training set: Not applicable, as this is not an AI/ML device relying on a training set.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

What the document does describe as proof of safety and effectiveness:

The submission relies on demonstrating substantial equivalence to an already legally marketed device (the GE LOGIQ 5 diagnostic ultrasound system, K014097). This is a common pathway for medical devices that are similar to existing ones.

The "proof" in this context is outlined in Section b):

Non-clinical Tests: The device was evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, and mechanical safety
- It was found to conform with applicable medical device safety standards.
Clinical Tests: "None required." This explicitly states that no clinical trials were deemed necessary by the FDA for this particular 510(k) submission, precisely because it was being cleared based on substantial equivalence.
Conclusion: GE Medical Systems asserts that the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound is substantially equivalent to devices currently cleared for market based on:
- Consistent intended uses and other key features with traditional clinical practice, FDA guidelines, and established methods of patient examination.
- Conformity of the design and development process with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
- Compliance with applicable medical device safety standards, verified through independent evaluation and ongoing factory surveillance.
- The long history of safe and effective performance of diagnostic ultrasound in general.

In summary, this document reflects a regulatory submission from 2003 for an ultrasound system, not an AI/ML device. Therefore, the detailed performance criteria and study design elements typically associated with AI/ML device validation are not present. Instead, "proof" of acceptance is based on compliance with manufacturing standards, non-clinical safety testing, and substantial equivalence to a predicate device already on the market.

Summary

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K032974

Attachment B:

OCT 2 1 2003

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

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has a swirling pattern, giving the logo a classic and recognizable appearance.

GE Ultrasound

GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue Milwaukee, WI 53219

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	September 23, 2003
2. Device Name:	GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound SystemUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
3. Marketed Device:	GE LOGIQ 5 diagnostic ultrasound system, 510(k) Numbers K014097 currently in

commercial distribution.

Device Description: The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system available in Expert (full featured) or Pro (reduced feature) versions consists of a mobile console approximately 52 cm wide. 99 cm deep and 135 cm high that provides digital image acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification adds coded pulse modes from high-end LOGIQ systems to the Expert version and removes provides limited options for the Pro version.
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; and Intraoperative (abdominal, thoracic, vascular and neurological).
Comparison with Predicate Device: The GE LOGIQ 5 Pro & Expert versions are comparable with and substantially equivalent to the current GE LOGIQ 5. They have technological characteristics, are comparable in kev safety and effectiveness features, utilize the same overall design, construction, and materials, and have the same intended uses and basic operating modes as the predicate device.

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 EN 46001 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 LOGIQ 5 Pro/Expert Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2003

Mr. Allen Schuh Manager, GE Ultrasound Safety GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219

Re: K032974

Trade Name: GE LOGIQ 5 Pro/Expert Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 23, 2003 Received: September 24, 2003

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 5 Pro/Expert Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C 3.5C

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

3.5Cs
 રુભ
 8C
E8C
BE9C
 7L
10L
12L
i 12L
 35
 78
 108
 6T
P2D
P6D

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

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

Page 3 - Mr. Schuh.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David Lezama

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}------------------------------------------------

Diaqnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert Ultrasound System

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
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	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
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P		P		P	P
Transvaginal	P	P	P		P		P	P
Transuretheral
Intraoperative[5]	P	P	P		P		P	P
Intraoperative Neurological	P	P	P		P		P	P
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmen

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 3C Transducer

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

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

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

[*] 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)

510(k) Number

David R. Lyman

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 3.5C Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	E	E	E		E	E	E	E	E	N
Abdominal[1]	E	E	E		E	E	E	E	E	N
Pediatric
Small Organ (specify)	E	E	E		E	E	E	E	E	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E		E	E	E	E	E	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E		E	E	E	E	E	N
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;

[4] Other use includes Urology;

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

David A. Segerson

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 3.5Cs Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	E	E	E		E	E	E	E	E	N
Abdominal[1]	E	E	E		E	E	E	E	E	N
Pediatric
Small Organ (specify)	E	E	E		E	E	E	E	E	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E		E	E	E	E	E	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E		E	E	E	E	E	N
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;

[4] Other use includes Urology;

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

David R. Benson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Deyices

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 5C Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P
Abdominal1	P	P	P		P		P	P
Pediatric	P	P	P		P		P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[1]	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;

[4] Other includes urology

[*] 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)

(Division Sign-Off)

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 8C 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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E	E	E	E	E	E	E	N
Pediatric	E	E	E	E	E	E	E	E	E	N
Small Organ (specify)	E	E	E	E	E	E	E	E	E	N
Neonatal Cephalic	E	E	E	E	E	E	E	E	E	N
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic;

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

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE

David A. Symm

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with E8C 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
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	N	N
Abdominal[1]	P	P	P		P		P	P	N	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	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P	N	N
Transvaginal	P	P	P		P		P	P	N	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)

Davidh Segunm
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K032474

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with BE9C Transducer

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	E	E	E	E	E	E	N	N
Abdominal[1]	E	E	E	E	E	E	N	N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	E	E	E	E	E	E	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	E	E	E	E	E	E	N	N
Transvaginal	E	E	E	E	E	E	N	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)

David A. Symm
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K032974

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 7L 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics	E	E	E		E	E	E	E	E	N
Abdominal	E	E	E		E	E	E	E	E	N
Pediatric
Small Organ [2]	E	E	E		E	E	E	E	E	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	E	E	E		E	E	E	E	E	N
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	N
Musculo-skeletal Superficial	E	E	E		E	E	E	E	E	N
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: [2] Small organ includes breast, testes, thyroid.

[*] Combined modes are B/M, B/Color 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 Deyice Evaluation (ODE)

David R. Bergman
(Division Sign-Off)

Division of Reproductiv e, Abdominal, and Radiological Dev

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 10L 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	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
Pediatric	P	P	P		P		P	P		N
Small Organ[2]	P	P	P		P		P	P		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P		P	P		N
Musculo-skeletal Conventional	P	P	P		P		P	P		N
Musculo-skeletal Superficial	P	P	P		P		P	P		N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]	P	P	P		P		P	P		N
Intraoperative Neurological	P	P	P		P		P	P		N
Intravascular
Laparoscopic

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

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

[5] Intraoperative includes abdominal, thoracic, and vascular.

[*] 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 Dence Evaluation (ODE)

510(k) Number

David A. Bergman

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 12L 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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P		P	P	P	N
Small Organ [2]	P	P	P		P		P	P	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P		P	P	P	N
Musculo-skeletal Conventional	P	P	P		P		P	P	P	N
Musculo-skeletal Superficial	P	P	P		P		P	P	P	N
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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniela Legson

(Division Sign-Off) 8 Division of Reproductive, Abdominal. and Radiological Devices

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with i12L 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Harmonic Modes	Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E		E	E	E	E
Pediatric	E	E	E		E	E	E	E
Small Organ (specify)	E	E	E		E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	E	E	E		E	E	E	E
Peripheral Vascular	E	E	E		E	E	E	E
Musculo-skeletal Conventional	E	E	E		E	E	E	E
Musculo-skeletal Superficial	E	E	E		E	E	E	E
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]	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 is via Intraoperative;

[3] Cardiac is Adult and Pediatric via Intraoperative;

[5] Intraoperative includes abdominal, thoracic, and vascular.

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

David A. Lymm
(Division Sign Off)

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 3S 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
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	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
Cardiac[3]	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
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/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

David A. Lynn
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 7S 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
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	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	P	P	P	P	P	P	P	P	P
Cardiac(3)	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
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.

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

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

Daniel Adelman

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 10S 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
Ophthalmic
Fetal / Obstetrics
Abdominal	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (specify)
Neonatal Cephalic	E	E	E	E	E	E	E	E	E
Adult Cephalic	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Symm

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with 6T 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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Legum
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with P2D 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
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac (3)				E
Peripheral Vascular				E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [3] Cardiac is Adult and Pediatric.

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

David A. Symm

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

Prescription User (Per 21 CFR 801.109)

E-18

{21}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 5 Pro/Expert with P6D Transducer

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

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

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

Notes: [3] Cardiac is Adult and Pediatric.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Legrom

(Divisi Off Dit "ictive, Abdominal, and : 510 .. J 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.