K Number

Device Name

GE LOGIQ 7 ULTRASOUND BT05

Manufacturer

GENERAL ELECTRIC CO.

Date Cleared

2005-09-21

(15 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal[1], Pediatric, Small Organ[2], Neonatal Cephalic, Adult Cephalic, Cardiac[3], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other[4], Transesophageal, Transrectal, Transvaginal, Intraoperative[5], Intraoperative Neurological.

Device Description

The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. The user interface includes a Computer Reyboard, Specialized official and a color video CRT or LCD image display & LCD touch panel. It provides digital acquisition, processing and display capability.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K010329, K032182, K04181

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets, which are typical for AI/ML-based devices.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis system" and a "full featured general purpose diagnostic ultrasound system," indicating its use for diagnosis rather than treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" identifies it as a "full featured general purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "full featured general purpose diagnostic ultrasound system" with hardware components like a computer keyboard, specialized controls, CRT/LCD display, and LCD touch panel. It is not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
Device Function: The description clearly states that the GE LOGIQ 7 is a "diagnostic ultrasound system." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method.
Intended Use: The intended uses listed are all related to imaging various parts of the human body directly, not analyzing samples taken from the body.

Therefore, based on the provided information, the GE LOGIQ 7 is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of: Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

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

For GE LOGIQ 7 Ultrasound System:

Clinical Application / Anatomy/Region of Interest: 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], Intraoperative Neurological, Intravascular, Laparoscopic.
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. Combined modes include real-time 3D and 4D acquisition when used with special 4D probes.

For GE LOGIQ 7 with 4C Transducer (new indications):

Clinical Application / Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal[1], Small Organ (specify), Peripheral Vascular, Other[4].
Notes: [1] Abdominal includes GYN; [4] Other use includes Urology;
Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

For GE LOGIQ 7 with 4D3C-L Transducer (new indications):

Clinical Application / Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal[1], Pediatric, Other[4].
Notes: [1] Abdominal includes GYN; [4] Other use includes Urology;
Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD. Combined modes include array motion in the elevational plane providing real-time 3D acquisition.

For GE LOGIQ 7 with 4D10L Transducer (new indications):

Clinical Application / Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ[2], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Notes: [2] Small organ includes breast, testes, thyroid.
Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD. Combined modes include array motion in the elevational plane providing real-time 3D acquisition.

For GE LOGIQ 7 with i739 or t739 Transducer (added under Appendix E):

Clinical Application / Anatomy/Region of Interest: Pediatric, Small Organ[2], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Exam Type, Means of Access: Intraoperative [5], Intraoperative Neurological.
Notes: [2] Small organ includes breast, testes, thyroid. [5] Intraoperative includes abdominal, thoracic, and vascular.
Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The GE LOGIQ 7 is a full featured general purpose diagnostic ultrasound system. The dimensions of the console are 100 cm deep and 140-160 cm (adjustable) high. The user interface includes a CRT or LCD image display & LCD touch panel, Computer keyboard, Specialized operational controls that provide digital acquisition, processing and display capability. It has capabilities for real-time acquisition, additional measurements and productivity enhancement.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Transesophageal, Intraoperative (abdominal, thoracic, vascular and neurosurgical), GYN/Pelvic, Urology/Prostate.

Indicated Patient Age Range

Adult and Pediatric (including Fetal and Neonatal).

Intended User / Care Setting

Qualified physician.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electrical and mechanical safety. The device was found to conform with applicable medical device safety standards. No clinical tests were required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K010329, K032182, K04181

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

K052441

SEP 2 1 2005

Special 510(k) Premarket Notification GE LOGIQ 7 Ultrasound BT05 September 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 is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The logo is black and white.

GE Healthcare

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

Section a):

| 1. | Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC
PO Box 414
Milwaukee, WI 53201 |
|----|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Allen Schuh,
Manager, Safety and Regulatory Engineering
Telephone: 414-647-4385; Fax: 414-647-4090 |
| | Date Prepared: | September 2, 2005 |
| 2. | Device Name: | GE LOGIQ 7 Diagnostic Ultrasound System, BT05
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
| 3. | Marketed Device: | GE LOGIQ 7 Diagnostic Ultrasound System K010329, K032182, K04181 |

3 3. Marketed Device: A device currently in commercial distribution.

Device Description: The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. 4. Device Describitori. The OC EOON Ploade, 100 cm deep and 140-160 cm (adjustable) high The user interface includes a that provides digital acquisition, processing and display capability. that provides "digital" acquisition, "processing" and a color video CRT or LCD image display & LCD touch panel. Computer Reyboard, Specialized official and a color rease acquisition, additional measurements and productivity enhancement.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation ാ. Indications for USC. The deville Io Incent (breast, thyroid); Neonatal Cephalic; Adult Cephalic; OF Fetal, Addonimal, Fediatio, Onliar Organ (Irondo, Releatal Conventional and Superficial, Gardias (addit and poditation), Polipiter researchageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Device: The GE LOGIQ 7 BT05 is of a comparable type and substantially o. Our partson with Fredicall Boths. It has the same technological characteristics, key safety and equivalent to the banon. De Lesign, 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, creaning and 1. Norrainidal rosts. The down has been , 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 5. Goricusion: michod doos and other key to see in and development process of the guldelines, and octorned model and ISO 13485 quality systems. The device manforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrassund has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ 7 BT04 Sale and onlootive performantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which are often interpreted as an abstract representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2005

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

Re: K052441

Trade Name: GE LOGIQ 7 Ultrasound System Trade Name: CE ES STORE FR 892.1550, 892.1560, and 892.1570 Regulation Name: Ultrasonic pulsed doppler imaging system Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer Regulatory Class: II

Product Code: IYN, IYO, and ITX

Dated: September 2, 2005

Received: September 6, 2005

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) promative is substantially equivalent (for the referenced above and we nave determined the arrily marketed predicate devices marketed in indications for use stated in the encreations of the enactment date of the Medical Device interslate commerce proc to May 20, 1970, the entired in accordance with the provisions of the Amendments, or to devices mat liave been receive, market the device, subject to Federal Food, Drug, and Cosmette Act. The general controls provisions of the Act include the general controls provisions of the Act. "The general of the super of the manufacturing practice, labeling, requirements against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I his determination of substantar equivalenee uppressions in your premarket notification:

Transducer Model Number

4C 4D3C-L 4D10L i739 or t739

Page 2 -- Mr. Schuh

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into entires major regulations affecting your device (roddition, FDA It may be subject to such additional controls: "Zhoting 21, Parts 800 to 898. In addition, FDA Can be found in the Code of I eachar roganized in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuance of a sucsainnial equirements of the Act
that FDA has made a determination that your device complies with other water that FDA has made a decidimation that Jour secred by other Federal agencies. You must or any Federal Statutes and regulations administers by of not limited to: registration and listing (21 comply with an the Act 3 requirements, news and acturing practice requirements as set CFK Fart 807), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (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 his determination of Substance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested Information, meruding acoused of the Center's September 30, 1997 "Information for Manufacturers" in Appendix CT, (enclosed) of the Center 3 Beptems and Transducers'. If the special Seeking Marketing Clearance of Diagnosto Of Diagram - Structic output greater than approved report is mobiliplete of commis unaceptation 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 The special report of & 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 I fills letter will anow you to oegin nameling your device to a legally marketed noutication. The I Driving of basian for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you ucsile specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Compilance at (21 notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainter nobilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Page 3 – Mr. Schuh . . . .

: :

. . . . . . . .

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

Sincerely yours,

David A. Ingram

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

Enclosure(s)

Comments of the comments of

. . . . . . . . . .

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 Ultrasound System

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	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
Cardiac[3]	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
Other[4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative[5]	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] Intracperative 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.

[ ] Sombinou modes real-time 3D and 4D acquisition when used with special 4D probes.

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

David R. Syverson

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

Prescription Use (Per 21 CFR 801.109)

E-2

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with 4C Transducer

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

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

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

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

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

David A. Leyson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K052441

Prescription Use (Per 21 CFR 801.109)

E-3

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with 4D3C-L Transducer

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

	Mode of Operation
Clinical
Application	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
Anatomy/Region of Interest
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
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

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

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

I I Combined model are bring in the elevational plane providing real-time 3D acquisition.

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

Daniel R. Larson

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

Prescription Use (Per 21 CFR 801.109)

E-4

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with 4D10L Transducer

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

						Mode of Operation
Clinical Application
Anatomy/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	N	N	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ[2]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

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

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

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

[ ] Ochained than anay motion in the elevational plane providing real-time 3D acquisition.

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

Davidh. Lymann

(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

દ-૨

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 7 with i739 or t739 Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ[2]	E	E	E	E	E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
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 (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative [5] (specify)	E	E	E	E	E	E	E	E	E
Intraoperative Neurological	E	E	E	E	E	E	E	E	E
Intravascular
Laparoscopic

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

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

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

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

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

David A. Leggrom
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

E-6

)