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 LOGIQ Twin is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 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 GE LOGIQ Twin Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system. Device performance and acceptance criteria are defined by substantial equivalence to a predicate device, the GE LOGIQ Book Diagnostic Ultrasound System (K014206 and K032477).

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria (Set by Substantial Equivalence to Predicate Device)	Reported Device Performance (GE LOGIQ Twin)
Same technological characteristics of design, construction, and materials as predicate device (GE LOGIQ Book K014206, K032477)	Confirmed. Device is a compact and portable unit having the same technological characteristics of design, construction, and materials as the predicate device.
Comparable in key safety features to predicate device	Confirmed. Evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical and mechanical safety. Found to conform with applicable medical device safety standards.
Comparable in key effectiveness features to predicate device	Confirmed. Key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.
Same intended uses as predicate device	Confirmed. 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.
Conformance with 21 CFR Part 820 (Quality System Regulation)	Confirmed. Design and development process conforms with 21 CFR 820.
Conformance with ISO 9001 and ISO 13485 quality systems	Confirmed. Design and development process conforms with ISO 9001 and ISO 13485.
Conforms to applicable medical device safety standards	Confirmed. Compliance verified through independent evaluation with ongoing factory surveillance.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is specified in the provided document for the substantial equivalence claim. The performance is assessed by comparison to the predicate device and adherence to industry standards, rather than direct performance metrics against a defined dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The study is based on substantial equivalence to a predicate device and conformance to safety and quality standards, not on expert-adjudicated test sets for performance metrics.

4. Adjudication Method for the Test Set

Not applicable. No specific test set adjudication method is mentioned as a clinical study on a defined test set was not performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Clinical Tests: None required."

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

Not applicable. This is a medical device (ultrasound system), not an algorithm or AI. Performance is assessed on its capabilities comparable to existing cleared devices and adherence to safety standards, not standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the safety and effectiveness of the legally marketed predicate device (GE LOGIQ Book Diagnostic Ultrasound System, K014206 and K032477) and conformance to recognized safety and quality standards (e.g., medical device safety standards, 21 CFR 820, ISO 9001, ISO 13485). It is not based on a specific clinical ground truth from patient data like pathology or outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as no training set for an algorithm was used.

Summary

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

K050126

FEB - 2 2005

Attachment B

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The circular shape has a decorative, swirling pattern around the letters. The logo is black and white.

GE Medical Systems

General Electric Company P.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, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	January 18, 2005
2. Device Name:	GE LOGIQ Twin Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
3. Marketed Device:	GE LOGIQ Book Diagnostic Ultrasound System, K014206 and K032477 currently

y in 3. Marketed Device. commercial distribution.

Device Description: The GE LOGIQ Twin is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 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 GE LOGIQ Twin is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ Book. It is a compact and readily portable unit having the same technological characteristics of design, construction, and materials; is comparable in key safety and effectiveness features; and has the same intended uses 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 quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ Twin Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

FEB - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Healthcare Company General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue WEST MILWAUKEE WI 53219

Re: K050126

Trade Name: GE LOGIQ Twin 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: January 18, 2005 Received: January 19, 2005

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 Twin Ultrasound System, as described in your premarket notification:

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

Transducer Model Number

4C-RS	8C-RS
3S-RS	i12L-RS
7S-RS	i/t739-RS
10S-RS	BE9C-RS
8L-RS	12L-RS
E8C-RS

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 it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous oncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that I Dr o lossantes over device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any I cuchar statutes and regulations and limited to: registration and listing (21 Comply with an the Her s requirements, with and manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordly in the quality bybents (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I has device, you submit a postclearance special report. This report should contain complete the first ucvice, you submit a possible in as a ments based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (cherosed) of allo Centres tic 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 I ne special report should 1010-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 nouthoution. The results in a classification for your device and thus permits your device to proceed to market.

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

Page 2 - Mr. Schuh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire of Compliance at (240) 276-0120. Also, please note the regulation entitled, ounder the Office or Centre to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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

Sincerely yours,

Daniel A. Lyman
N. S. Board

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

Enclosure(s)

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin 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	N	P	N	P	P	N	N
Abdominal[1]	P	P	P	N	P	N	P	P	P	N
Pediatric	P	P	P	N	P	N	P	P	P	N
Small Organ[2]	P	P	P	N	P	N	P	P	P	N
Neonatal Cephalic	P	P	P	N	P	N	P	P	P	N
Adult Cephalic	P	P	P	N	P	N	P	P	P	N
Cardiac[3]	P	P	P	N	P	N	P	P	P	N
Peripheral Vascular	P	P	P	N	P	N	P	P	P	N
Musculo-skeletal Conventional	P	P	P	N	P	N	P	P	P	N
Musculo-skeletal Superficial
Other[4]	P	P	P	N	P	N	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	N	P	N	P	P	N	N
Transvaginal	P	P	P	N	P	N	P	P	N	N
Transuretheral
Intraoperative	P	P	P	N	P	N	P	P	P	N
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)

Daniel K. Inouye

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 4C-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N	N
Abdominal[1]	N	N	N		N		N	N	N	N
Pediatric	N	N	N		N		N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N	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;

[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)

David K. Lyzman

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 3S-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse*	Other
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	P	P	P	N	P	N	P	P	P	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	N	P	N	P	P	P	N
Cardiac[3]	P	P	P	N	P	N	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	N	P	N	P	P	P	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/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.

[*] 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)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 5 ! (J(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 7S-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)[2]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N	N	N
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)

David A. Lamm

(Division Sign-Off) Division of Reproductive, Abdomina Prescription User (Per 21 CFR 801.109) Ind Radiological Device 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 10S-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	- M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ (specify)[2]
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac [3]	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular
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/Pelvic.

[3] Cardiac is Adult and Pediatric.

[*] 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)

David A. Symm

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 8L-RS Transducer

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

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

Danila. Sgam

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with E8C-RS Transducer

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
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P
Abdominal[1]	P	P	P		P		P	P
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
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P
Transvaginal	P	P	P		P		P	P
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)

Eamil A. Syrm

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 8C-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[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
I anarosconic

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)

David G. Ingram

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with i12L-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P	N
Pediatric	P	P	P		P		P	P	P	N
Small Organ (specify)[2]	P	P	P		P		P	P	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	N
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)

Prescription User (Per 21 CFR 801.109)

Daniel A. Layman

E-10

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with i/t739-RS Transducers

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
Pediatric	E	E	E		E		E	E	E
Small Organ (specify)[2]	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
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[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: [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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lyons

(Division Sign-Off) Division of Reproductive. Abdom E-11 and Radiological Devices 510(k) Number __

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with BE9C-RS Transducer

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Danielle. Lynn

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Twin with 12L-RS 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
Abdominal
Pediatric	N	N	N	N	N	N	N	N
Small Organ[2]	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N
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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seegmiller

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.