The LOGIQ 700 with B-flow is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus.

Device Description

The LOGIQ 700 with B-flow consists of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. The addition of Bflow to the LOGIQ 700 extends the B mode imaging capability of blood flow, providing the user with enhanced visualization of flow and qualitative assessment.

AI/ML Overview

The GE LOGIQ 700 Diagnostic Ultrasound System with B-flow Modification, as described in the provided documentation, did not undergo specific performance studies with acceptance criteria to prove its effectiveness for the B-flow modification.

Instead, its clearance was based on substantial equivalence to a previously marketed device (GE LOGIQ 700) and adherence to safety standards. The B-flow modification was considered an extension of existing B-mode imaging capabilities, with acoustic output levels equivalent to or less than color Doppler imaging, which was already established in the predicate device.

Therefore, many of the typical categories for AI/ML device studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this case because the device's clearance was not based on such performance studies for the B-flow feature.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance	Notes
B-flow Modification Performance	No specific performance acceptance criteria for the B-flow modification are mentioned.	"B-flow provides the user with enhanced visualization of flow and qualitative assessment."	The efficacy of B-flow was not quantified with specific metrics. Its value was presented as an enhancement to existing B-mode.
Acoustic Output	Conformity with applicable medical device safety standards.	Acoustic output levels equivalent to or less than color Doppler imaging.	This indicates that the B-flow modification did not introduce new acoustic risks beyond what was already cleared for color Doppler.
Biocompatibility	Conformity with applicable medical device safety standards.	Device found to conform.	Standard safety assessment.
Thermal, Electrical, and Mechanical Safety	Conformity with applicable medical device safety standards.	Device found to conform.	Standard safety assessment.
Quality System	Conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & 13485 quality system standards.	Conforms with regulations and standards.	Manufacturing and design process standards.

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

Not applicable. No clinical performance test set was used for the B-flow modification. The clearance was based on substantial equivalence to the predicate device and non-clinical evaluations.

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

Not applicable. No test set with ground truth established by experts was used for the B-flow modification.

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

Not applicable. No test set requiring expert adjudication was used for the B-flow modification.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC comparative effectiveness study was not performed for the B-flow modification. The B-flow modification is an imaging enhancement feature, not an AI-assisted diagnostic tool in the sense of comparing human reader performance with and without AI.

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

Not applicable. B-flow is an imaging mode on an ultrasound system, not a standalone algorithm.

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

Not applicable. For the B-flow modification, there was no ground truth used in a clinical performance study. The device's safety and effectiveness were established through non-clinical tests (acoustic output, biocompatibility, safety) and comparison to a predicate device.

8. The sample size for the training set:

Not applicable. This device is an ultrasound imaging system with a new imaging mode (B-flow), not an AI/ML algorithm that requires a "training set" in the conventional sense. The B-flow technology is an implementation of B-mode technology for blood flow visualization.

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

Not applicable. As above, there was no training set for this device.

Summary

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2/c/cc

Section 2:

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

Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular border. The border has a swirling or wave-like pattern around the letters. The logo is black and white.

GE Medical Svstems

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

Section a):

GE Medical Systems 1. Submitter: PO Box 414 Milwaukee, WI 53201 Contact Person: Allen Schuh, Manager, Safety and Regulatory Engineering Telephone: 414-647-4385, Fax: 414-647-4090 November 11, 1998 Date Prepared:
1. Device Name: GE LOGIQ 700 Diagnostic Ultrasound System with B-flow Modification. Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO

Marketed Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Numbers K930768 and K960527, currently in commercial distribution.
Device Description: The LOGIQ 700 with B-flow consists of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. The addition of Bflow to the LOGIQ 700 extends the B mode imaging capability of blood flow, providing the user with enhanced visualization of flow and qualitative assessment.
Indications for Use: The LOGIQ 700 with B-flow is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus.
Comparison with Predicate Device: The GE LOGIQ 700 Diagnostic Ultrasound System with B-flow is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 700. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, transducers and operating modes as the predicate device.

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. The B-flow imaging is implemented with B mode technology having acoustic output at levels equivalent or less than color Doppler imaging.
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 Quality System Regulation and ISO 9001 & 13485 quality sytem standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing 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 700 with B-flow is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

K990226

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

FEB - 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems, Inc. C/o Chantel Carson Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062-2092

K990226 Re: GE LOGIC700 Diagnostic with B-Flow Requlatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: January 21, 1998 Received: January 25, 1998

Dear Ms. Carson:

We have reviewed your Section 510(k) 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 Logic700 Diagnostic Ultrasound System with B-flow, as described in your premarket notification:

Transducer Model Number

739L**	326s	739t	548c	M12L
348c**	547L	618e	227s	M3c
546L**	739I	618c	LA39

**Probes to which B-Flow Modification Apply

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Druq Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

.. ..

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

Page 2 - Chantel Carson

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809:10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Robert A. Phillips, Ph.D. at (301) 594-1212.

Sincerely yours,

David A. Severson

Capt. Daniel C. Schultz, M.D. Acting, Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic		P	P	P		P	P		P
Adult Cephalic
Cardiac		P	P	P		P	P		P
Transesophageal
Transrectal		P	P	P		P	P		P
Transvaginal		P	P	P		P	P		P
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify)		P	P	P		P	P		P

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid. Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD K964617 Intraoperative includes abdominal organs. K964886, Musculo-skeletal added via K960527

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devi

510(k) Number .

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 326s Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		P	P	P		P	P		P

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid. Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD K964617

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

David le. Siggson

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

510(k) Number K990226

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 547L Transducer

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

Clinical Application	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify		P	P	P		P	P		P

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

David h. Seymour

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

Radiological Devices
510(k) Number K990226

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 739L Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify)		P	P	P		P	P		P

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Bergman

(Division Sign-Off) 6 Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

A-4

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 739i Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P	P		P	P	P
Intraoperative Neurological		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
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P	P		P	P	P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Small organ includes breast, testes, thyroid. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD Intraoperative includes abdominal organs. K964886

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

David A. Symon

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 739t Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P	P	P	P		P
Intraoperative Neurological		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
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Small organ includes breast, testes, thyroid. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD Intraoperative includes abdominal organs. K964886

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Javid A. bezonn
(Division Sign-Off)

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

A-6

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 618e Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P	P	P
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	P	P
Transvaginal		P	P	P		P	P	P	P
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify		P	P	P		P	P	P	P

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid.

Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Wyman
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 618c Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)
Neonatal Cephalic		P	P	P		P	P		P
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify

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

David A. Bergman

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 548c Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		P	P	P		P	P		P

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

David h. Sypman

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

Radiological Devices
510(k) Number K990226

Prescription User (Per 21 CFR 801.109)

A-9

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 348c Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify		P	P	P		P	P		P

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

David A. Bergman

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

510(k) Number

A-10

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 227s Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify		P	P	P		P	P		P

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid.

Other includes urological. Combined modes are B/M, B/Color, B/Color/PWD K964617

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

David h. Seppern

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

510(k) Number K990226

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with 546L Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify		P	P	P		P	P		P

(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)

Ehrid h. Sypm

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

A-12

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with LA39 Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal
Intraoperative (specify)		P	P	P		P	P		P
Intraoperative Neurological		P	P	P		P	P		P
Pediatric		P	P	P		P	P		P
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify		P	P	P		P	P		P

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

David C. Seyenson

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

510(k) Number .

A-13

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with M12L Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P
Musculo-skeletal Superficial		P	P	P		P	P		P
Other (specify)		P	P	P		P	P		P

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

Daniel h. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological D

510(k) Number

A-14

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

. . . .

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 700 with M3c Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify		P	P	P		P	P		P

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

Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast, testes, thyroid.

Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD K964617

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

Daniel h. Seymon
(Division Sign-Off)

510(k) Number

Division of Reproductive, Abdomina and Radiological Dev

Prescription User (Per 21 CFR 801.109)

A-15

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.