Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with digital processing and display capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The description of the device and its functions aligns with conventional ultrasound technology.

Therapeutic

No.
The device is described as a "general-purpose ultrasound system" and "general-purpose imaging and analysis system" providing "real-time digital acquisition, processing and display capability" for various clinical applications, all of which fall under diagnostic imaging rather than therapy.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is a "general-purpose ultrasound system" used for various clinical applications and exam types (e.g., Fetal, Abdominal, Cardiac), which are diagnostic purposes. Additionally, the "Input Imaging Modality" section mentions "Diagnostic ultrasound imaging or fluid flow analysis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console with keyboard, specialized controls, a color video LCD display with electronic array transducers," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states the device is a "general-purpose ultrasound system" used for "real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation." The listed clinical applications and anatomical sites are all related to imaging the inside of the body using ultrasound waves.
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to generate and interpret images based on ultrasound reflections.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).

Product codes

IYN, IYO, ITX

Device Description

The subject device consists of a mobile console with keyboard. specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging or fluid flow analysis

Anatomical Site

Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate);

Indicated Patient Age Range

Pediatric, Adult

Intended User / Care Setting

Not Found

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)

The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

K060993 LOGIQ P5/A5 Ultrasound System, K092271 LOGIO E9 Ultrasound System

Reference Device(s)

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

0

K101878

.

:

Addi 31 2010

Section 5: 510(k) Summary

LOGIQ P5 BT11

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected in a flowing, cursive-like manner.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance. The logo is in black and white.

K101878
AUG 3 1 2010

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

July 1, 2010 Date:

Submitter: GE Healthcare [GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC] 9900 Innovation Dr Wauwatosa, WI 53226

Primary Contact Person:

Bryan Behn Regulatory Affairs Manager

GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC.] T:(414)721-4214 F:(414)918-8275

Secondary Contact Person:

Jim Turner

Regulatory Affairs Manager America's Service GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

T:(262) 544-3359

F:(414)908-9225

Trade Name: LOGIQ P5 BT11 Ultrasound System

Device:

Common/Usual Name: LOGIQ P5 BT11

Classification Names: Class II

Product Code:

Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Predicate Device(s): K060993 LOGIQ P5/A5 Ultrasound System

K092271 LOGIO E9 Ultrasound System

The subject device consists of a mobile console with keyboard. Device Description: specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The device is a general-purpose ultrasound system. Specific Intended Use: clinical applications and exam types include: Fetal; Abdominal

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(renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro.

3

Image /page/3/Picture/0 description: The image shows the text "GE Healthcare". The text is in a sans-serif font and is black. The background is white.

510(k) Premarket Notification Submission

Technology:

Determination of Substantial Equivalence:

The LOGIQ P5 BT11 employs the same fundamental scientific technology as its predicate devices.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ P5 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews .
. Design Reviews
Testing on unit level (Module verification)
. Integration testing (System verification)
� Final Acceptance Testing (Validation)
. Performance testing (Verification)
Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the LOGIQ P5 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Dr. WAUWATOSA WI 53226

AUG 3 1 2010

Re: K101878

Trade/Device Name: LOGIQ P5 BT11 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 26, 2010 Received: July 27, 2010

Dear Mr. Behn:

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 LOGIQ P5 BT11 Ultrasound System, as described in your premarket notification:

Transducer Model Number

i12L
BE9CS
3CRF
3Sp
5Sp
4D8C
11L

5

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 895. 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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.

Sincerely yours,

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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AUG 31

2010

510(k) Number (if known):

Device Name: LOGIQ P5 BT11

Indications for Use:

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Besiee

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sat

510K K101878

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and connected, creating a monogram-like design. The logo appears to be a vintage or older version, as indicated by the slightly distressed or aged texture of the image. The overall impression is that of a classic brand emblem.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P5 Uitrasound System

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

Clinical Application		Mode of Operation
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	P	P	P	P	P	P	P	P	P	P	P
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	P,[6]
Pediatric	P	P	P	P	P	P	P	P	P	P	P,[6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	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	[6]
Musculo-skeletal
Conventional	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal
Superficial	P	P	P	P	P	P	P	P	P	P	[6]
Other[4]	P	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
Transvaginal	P	P	P		P		P	P	P	P
Transuretheral
Intraoperative[5]	P	P	P		P	P	P	P	P	P	[6]
Intraoperative
Neurological	P	P	P		P	P	P	P	P	P	[6]
Intravascular

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

[1] Abdominal includes renal, GYN/Pelvic Notes:

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[6] Elastography Imaging

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[**] Other mode is 4D / Realtime 3D

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Concurrence of CDRH, Office of Device-Evaluation (GBC)

Prescription User (Per 21 CFR 801.109)

uation(BSE) OIVID

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101878

8

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is depicted in black and white, with the letters and border appearing in black against a white background. The design has a vintage or classic feel due to its style and the slightly distressed appearance of the image.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with i12L Transducer

the time and place of trial.

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

Clinical Application	Mode of Operation
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
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]	P	P	P	P	P	P	P	P	P
Intraoperative
Neurological	E	E	E	E	E	E	E	E	E
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA (Logig 9 K030934); E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[**] Other mode is 4D / Realtime 3D

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Concurrence of CDRH, Office of Device Exatuation (900) OLD VO

510K

Prescription User (Per 21 CFR 801.109)

AZVP

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(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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Image /page/9/Picture/0 description: The image shows a logo with the letters 'GE' intertwined in a circular design. The letters are stylized and connected, creating a monogram-like appearance. The logo is black and white, with the letters and the outline of the circle appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P6 with BE9CS Transducer

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

Clinical Application		Mode of Operation
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Harmonic
Modes*	Harmonic
Imaging	Coded
Pulse	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]	E	E	E	E	E	E	E	E	E
Exam Type, Means of Access
Transesophageal
Transrectal	E	E	E	E	E	E	E	E	E
Transvaginal	E	E	E	E	E	E	E	E	E
Transuretheral
Intraoperative[5]
Intraoperative
Neurological
Intravascular

N = new indication; P = previously cleared by FDA; E = added under Appendix E(Minor modification to BE9C)

[1] Abdominal includes renal, GYN/Pelvic Notes:

[2] Small organ includes breast, testes, and 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 8/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[**] Other mode is 4D / Realtime 3D

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Concurrence of CDRH, Office of Bevios Evatuation (005) C

. .

510K

Prescription User (Per 21 CFR 801.109)

19

(Division Sign-Off) Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluatio

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 3CRF Transducer

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

Clinical Application		Mode of Operation
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		P	P	P		P		P	P
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric
Small Organ(2)
Neonatal Cephalic
Adult Cephalic
Cardiacia
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Otherf4	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperativel5)
Intraoperative
Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic Notes:

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

[**] Other mode is 4D / Realtime 3D

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Concurrence of CDRH, Office of Seviga Evaluation (ADE) OI

、・

510K

Prescription User (Per 21 CFR 801.109)

20

(Division Sign-OM) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

11

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and flourishes, giving the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P6 with 3Sp Transducer

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

Clinical Application		Mode of Operation
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Harmonic
Modes*	Harmonic
Imaging	Coded
Pulse	Other
**
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E	E	E	E	E	E	E	E
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
Intraoperative
Neurological
Intravascular
I anamennin

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, and thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[**] Other mode is 4D / Realtime 3D

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Concurrence of CDRH, Office of Begines Pratmation (0BB

Prescription User (Per 21 CFR 801.109) ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

12

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ P6 with 5Sp Transducer

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

Clinical Application	Mode of Operation
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
Abdominal[1]
Pediatric	E	E	E	E	E	E	E	E	E	E
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
Intraoperative
Neurological
Intravascular

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, and 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.

[**] Other mode is 4D / Realtime 3D

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

Concurrence of CDRH, Office of Bowice Examation (0)B

Prescription User (Per 21 CFR 801.109)

OIC

(Division Sign-Off)

510K

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white, with the letters and border in black and the background in white.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 4D8C Transducer

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

Clinical Application	Mode of Operation
Anatomy/Region of
Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Harmonic
Modes*	Imaging	Coded
Pulse	Other
**
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P	P
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

N = new indication; P = previously cleared by FDA (LOGIQ 9 K061129); E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic Notes:

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[**] Other mode is 4D / Realtime 3D

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

Concurrence of CDRH, GME of Desice Bruitiation (ABE

Prescription User (Per 21 CFR 801.109)

OIVO

(Division Sign-Off)

510K

23

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE LOGIQ P6 with 11L Transducer

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

Clinical Application	Mode of Operation
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
Abdominal[1]	P	P	P	P	P	P	P	P	P	[6]
Pediatric	P	P	P	P	P	P	P	P	P	[6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	[6]
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

N = new indication; P = previously cleared by FDA(LOGIQ E9 K092271); E = added under Appendix E

[1] Abdominal includes renal, GYN/Petvic Notes:

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[6] Elastography Imaging

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

1**1 Other mode is 4D / Realtime 3D

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

Concurrence of CDRH, Office of Beating Evelusion (GDG)

Prescription User (Per 21 CFR 801.109)

OIVD

(Division Sign-Off)
Division of Radiological Devices

. Office of In Vitro Diagnostic Device Evaluation and Safety

510K

24