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 Supertional and Supertional and Superticial, Urology (including prostate); Transvaginal; and Intractir Onlinemional; and and neurosurgical).

Device Description

The GE LOGIQ 9 is a full-featured general-purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LOD display and LCD touch panel. This modification will provide users with an intima media thickness measurement tool and enhanced 3D image manipulation.

AI/ML Overview

The provided text is a 510(k) premarket notification for the GE LOGIQ 9 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested elements for a study showing acceptance criteria are not directly present in this submission.

Specifically, this submission states:

"Clinical Tests: None required." This indicates that for this particular submission, no new clinical performance study was conducted to establish acceptance criteria or demonstrate the device meets them, as the device is considered substantially equivalent to a previously cleared device.
The primary method for demonstrating safety and effectiveness is through comparison to a predicate device, specifically the "current GE LOGIQ 7."

Therefore, I cannot provide detailed information about acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, or adjudication methods for clinical performance, as these were not required or performed for this 510(k) submission.

However, I can extract information related to the device's technical specifications and intended uses, which serve as criteria for this type of submission:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Device Equivalence)	Reported Device Performance (GE LOGIQ 9 BT07)
Technological Characteristics: Comparable to predicate device.	"Same technological characteristics."
Key Safety and Effectiveness Features: Same as predicate device.	"Same key safety and effectiveness features."
Physical Design, Construction, and Materials: Same as predicate device.	"Same physical design, construction, and materials."
Intended Uses: Same as predicate device.	"Same intended uses."
Basic Operating Modes: Same as predicate device.	"Same basic operating modes."
Diagnostic Ultrasound Evaluation: For Fetal; Abdominal; Pediatric; Small Organ; Neonatal/Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal (Conventional and Superficial); Urology; Transvaginal; Intraoperative; Intraoperative Neurological.	The device is intended for use in these applications across various modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse).
Acoustic Output: Conforms with applicable medical device safety standards.	"Has been evaluated for acoustic output... and has been found to conform with applicable medical device safety standards."
Biocompatibility: Conforms with applicable medical device safety standards.	"Has been evaluated for... biocompatibility... and has been found to conform with applicable medical device safety standards."
Cleaning and Disinfection Effectiveness: Conforms with applicable medical device safety standards.	"Has been evaluated for... cleaning and disinfection effectiveness... and has been found to conform with applicable medical device safety standards."
Thermal, Electrical, and Mechanical Safety: Conforms with applicable medical device safety standards.	"Has been evaluated for... thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards."
Quality Systems: Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485.	"The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems."

Here's the breakdown of the other requested information, based on the provided text:

1. A table of acceptance criteria and the reported device performance: See table above. The "acceptance criteria" in this context are primarily the characteristics of the predicate device and relevant safety standards, which the GE LOGIQ 9 BT07 is deemed to meet by being substantially equivalent.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented as "Clinical Tests: None required." The assessment is based on demonstrating substantial equivalence to a predicate device and adherence to safety standards, not a new clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert-established ground truth was performed or presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed or presented.
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: Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool leveraging human readers. No MRMC study was reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm submission. The device is a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a new clinical performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (GE LOGIQ 7) and adherence to recognized medical device safety standards.
8. The sample size for the training set: Not applicable. This submission does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established: Not applicable. This submission does not involve a "training set" or its ground truth establishment.

Summary

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Attachment B:

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 'g' and 'e' intertwined within a circular shape. There are three curved, pointed shapes evenly spaced around the outside of the circle.

GE Healthcare

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:	Patricia Taige,Safety and Regulatory EngineerTelephone: 414-721-3222; Fax: 414-721-3854
	Date Prepared:	April 18, 2006
2.	Device Name:	GE LOGIQ 9 Diagnostic Ultrasound BT07,Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN

Marketed Device: GE LOGIQ 9 Diagnostic Utrasound System K011188/K030934/K032656/K040251 A device currently in commercial distribution.
Device Description: The GE LOGIQ 9 is a full-featured general-purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LOD display and LCD touch panel. This modification will provide users with an intima media thickness measurement tool and enhanced 3D image manipulation.
Indications for Use: The device is intended for use by a qualified physician for u'trasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular, Musculo-skeletal Conventional and Supertional and Supertional and Superticial, Urology (including prostate); Transvaginal; and Intractir Onlinemional; and and neurosurgical).
Omnarison with Predicate Device: The GE LOGIQ 9 BT07 is of a comparable type and substantially equivalent to the current GE LOGIQ 7. It has the same technological chargeristians key safety and effectiveness features, physical design, construction, and materials, and has 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 themal, 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 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical devices, to stadio stardards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. "Diagnotic and as accumulated a long history of BT07 Diagnostic Ultrasound is substantially equivalent with respect to safety and the GE LOGIA 9
currently closed for modest currently cleared for market.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 1 2006

Ms. Patricia Taige Safety & Regulatory Engineer General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 99000 Innovation Drive WAUWATOSA WI 53226

Re: K061129

Trade Name: GE LOGIQ 9 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: IYN, IYO, and ITX Dated: April 19, 2006 Received: April 24, 2006

Dear Ms. Taige:

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 9 Ultrasound System, as described in your premarket notification:

Image /page/1/Picture/11 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. The logo is circular and contains the letters FDA in bold. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font.

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Transducer Model Number

4D8C
4D16L
4C
9L
i739 or t739
P5D

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.

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

Page 3 - Ms. Taige

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

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

Sincerely yours,

David h. Lynn

Image /page/3/Picture/5 description: The image contains a handwritten word, "for", in cursive script. The letters are connected, with the "f" having a prominent loop extending below the baseline. The "o" and "r" are smaller and connected to the "f".

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

Enclosure

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 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	P
Abdominal1	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ2	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac3	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P
Other4	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative5	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	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)

David A. Leppan

(Division ) Division and Radi 510(k) Numbe

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with 4D8C 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	E	E
Abdominal[1]	E	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E	E
Small Organ[2]	E	E	E	E	E	E	E	E	E	E
Neonatal Cephalic	E	E	E	E	E	E	E	E	E	E
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
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

[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)

David A. Legron

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with 4D16L 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]	E	E	E	E	E		E	E	E	E
Pediatric	E	E	E	E	E		E	E	E	E
Small Organ[2]	E	E	E	E	E		E	E	E	E
Neonatal Cephalic	E	E	E	E	E		E	E	E	E
Adult Cephalic
Cardiac [3]
Peripheral Vascular	E	E	E	E	E		E	E	E	E
Musculo-skeletal Conventional	E	E	E	E	E		E	E	E	E
Musculo-skeletal Superficial	E	E	E	E	E		E	E	E	E
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
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

[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)

David h. begram

(Division Sign-Off) Division of Reproductive, Abdominal, Ond Radiological Devices : 1 ป(k) Number ______________________________________________________________________________________________________________________________________________________________

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with 4C 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	E
Abdominal[1]	E	E	E		E	E	E	E	E	E
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E
Musculo-skeletal Superficial
Other[4]	E	E	E		E	E	E	E	E	E
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
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

[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. Seymore

(Division Sian-Off) Division of Reproductive, Abdomina and Radiological Device 610(k) Number

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with 9L 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
Abdominal[1]	E	E	E		E		E	E	E	E
Pediatric
Small Organ[2]	E	E	E				E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E		E		E	E	E	E
Musculo-skeletal Conventional	E	E	E		E		E	E	E	E
Musculo-skeletal Superficial	E	E	E		E		E	E	E	E
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
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

[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)

David A. Beynon

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with i739 or t739 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)
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac(3)
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative(5)	E		E		E	E	E	E	E	E
Intraoperative Neurological	E		E		E	E	E	E	E	E
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)

David G. Ingram

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

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 9 with P5D 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]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular				E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
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

{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. Larson

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