Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatic); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional; Transrectal; and Transvaginal.

Device Description

The GE LOGIQ Book BT03 is a compact and portable diagnostic ultrasound system with integrated keyboard, LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 35 cm wide, 28 cm deep and 8 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard with an intuitive layout of imaging controls, track-ball, color GUI display and Doppler audio.

AI/ML Overview

The GE LOGIQ Book BT03 Ultrasound System, as described in K032477, is a diagnostic ultrasound system. It is important to note that this 510(k) pertains to a traditional submission for an ultrasound system, which relies on demonstrating substantial equivalence to a predicate device rather than on performance against specific acceptance criteria derived from a novel clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

For ultrasound systems cleared through a 510(k), acceptance criteria are typically met through a demonstration of substantial equivalence to a legally marketed predicate device, adherence to medical device safety standards, and verification of device specifications. "Performance" in this context refers to the device's adherence to those standards and its comparability to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicit from 510(k) and general ultrasound device requirements)	Reported Device Performance (Summary from K032477)
Substantial Equivalence	Comparable technological characteristics, design, construction, and materials to predicate device (GE LOGIQ Book, K014206).	The GE LOGIQ Book BT03 is "of a comparable type and substantially equivalent to the currently marketed GE LOGIQ Book. It has the same technological characteristics of design, construction, and materials; is comparable in key safety and effectiveness features."
Safety Standards	Conformance with applicable medical device safety standards for acoustic output, biocompatibility, thermal, electrical, and mechanical safety.	"The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards."
Quality System Compliance	Design and development process conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & ISO 13485 quality system standards.	"The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & ISO 13485 quality system standards."
Intended Use	The device's clinical applications and modes of operation align with those previously cleared or being introduced for the first time as equivalent.	The system is a "general purpose ultrasound system" with specific clinical uses including Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal and Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Transrectal, and Transvaginal. The detailed "Indications for Use Forms" for the system and each transducer (3C-RS, 8C-RS, E8C-RS, 10LB-RS, 12L-RS, 8L-RS, 3S-RS) specify the modes of operation (B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) available for each clinical application, indicating which are "P" (previously cleared) or "N" (new indication) or "E" (added under Appendix E).
Post-Clearance Requirement	Submission of a postclearance special report with complete information, including acoustic output measurements based on production line devices.	FDA approval is granted "on the condition that prior to shipping the first device, you submit a postclearance special report... contain complete information, including acoustic output measurements based on production line devices."

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

The 510(k) summary explicitly states: "Clinical Tests: None required." This indicates that no new clinical study was conducted with a specific "test set" in the traditional sense for the purpose of demonstrating performance against acceptance criteria for this 510(k) submission. The device's performance was largely demonstrated through engineering and safety testing, and its substantial equivalence to a predicate device.

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

As no clinical tests were required or conducted as part of this 510(k) submission, there was no "test set" and consequently no experts used to establish ground truth for such a set.

4. Adjudication Method for the Test Set

Since no clinical tests were required or conducted, no adjudication method was used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or indicated as being performed for this 510(k) submission. Therefore, no effect size of human readers improving with or without AI assistance can be determined from this document.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This submission is for a diagnostic ultrasound system, which is an imaging device. It does not describe an AI algorithm or software intended for standalone diagnostic performance. Therefore, no standalone algorithm-only performance study was conducted.

7. The Type of Ground Truth Used

As no clinical studies were performed, there was no ground truth (expert consensus, pathology, or outcomes data) established for a test set for this 510(k). The regulatory pathway relied on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than proving efficacy through clinical outcome measures from a new study.

8. The Sample Size for the Training Set

Since no AI algorithm's performance was being evaluated in this submission, there was no "training set" in the context of machine learning.

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

As there was no AI training set, no ground truth was established for it.

Summary

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K032477

Traditional 510(k) Premarket Notification GE Medical Systems - GE LOGIQ Book BT03 Ultrasound System August 8, 2003

Section 2: 510(k) Summary Per 21 CFR Part 807.92.

GE Medical Systems

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

Section a):

1. Submitter: GE Medical Systems PO Box 414 Milwaukee, WI 53201
  Allen Schuh. Contact Person: Manager, Safety and Regulatory Engineering Telephone: 414-647-4385, Fax: 414-647-4090

August 8, 2003 Date Prepared:

GE LOGIQ Book Diagnostic Ultrasound System 2. Device Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
1. Marketed Device: GE LOGIQ Book BT03 is substantially equivalent to the GE LOGIQ Book, 510(k) Number K014206, a device currently in commercial distribution.

Device Description: The GE LOGIQ Book BT03 is a compact and portable diagnostic ultrasound system with integrated keyboard, LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 35 cm wide, 28 cm deep and 8 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard with an intuitive layout of imaging controls, track-ball, color GUI display and Doppler audio.
Indications for Use: The GE LOGIQ Book BT03 is a general purpose ultrasound system. Specific clinical uses include Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatic); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional; Transrectal; and Transvaginal.
Comparison with Predicate Device: The LOGIQ Book BT03 is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ Book. It is has the same technological characteristics of design, construction, and materials; is comparable in key safety and effectiveness features. It is being updated with additional transducers to provide new indications consistent with other GE LOGIQ systems.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, and 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 Quality System Regulation and ISO 9001 & ISO 13485 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified by independent test house evaluation with onqoing production 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 Book BT03 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

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

Re: K032477

Trade Name: GE LOGIQ Book BT03 Diagnostic 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 trasducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: October 6, 2003 Received: October 7, 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 Book BT03 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C-RS 8C-RS

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E8C-RS
10LB-RS
12L-RS
8L-RS
3S-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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special 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.

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Page 3 - Mr.Schuh

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,

Nancy C. Brogdon

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

Enclosure(s)

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KO32477

Traditional 510(k) Premarket Notification GE Medical Systems - GE LOGIQ Book Ultrasound March 8, 2002

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book Ultrasound System

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	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[2]	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P
Adult Cephalic	N	N	N	N	N	N	N
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]	P	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	N	N	N	N	N	N	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.

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

Nancy C. Brandon
(Division Sign-Off)

Division of Reprodu and Radiological Devic 510(k) Numb

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book with 3C-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	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[3]	P	P	P		P		P	P	P
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
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.

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

Maurice C. Gordon

(Division Sign-Off Division of Reproduct and Radiological Device 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book with 8C-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
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	E	E	E	E	E	E	E
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
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)

Nancy C. Brogdon

(Division Sign-Division of Reproduc and Radiological Devic 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book with E8C-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	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
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)

NancyC Brogdon

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

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book with 10LB-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
Ophthalmic
Fetal / Obstetrics							P	P
Abdominal	P	P	P		P		P	P
Pediatric	P	P	P		P		P	P
Small Organ[2]	P	P	P		P		P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P		P	P
Musculo-skeletal Conventional	P	P	P		P		P	P
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
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)

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

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N	N
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[3]	N	N	N		N		N	N	N	N
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]	N	N	N		N		N	N	N	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal is via Intraoperative;

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

[3] Cardiac is Adult and Pediatric via Intraoperative;

[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 Device Evaluation (ODE)

Nancy C. Brandon
(Division Sign-Off)

Division of Reproductive, ano Radiological Device 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

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

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

Notes: [1] Abdominal is via surface or Intra-operative;

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

[3] Cardiac is Adult and Pediatric via Intra-operative;

[5] Intra-operative 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 Device Evaluation (ODE)

Nancyl Brogdon
Division Sign-Off

"sion of Reprodu D Open Number

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ Book 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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N		N		N	N	N
Cardiac[3]	N	N	N		N		N	N	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4] (specify)	N	N	N		N		N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032477

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.