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).

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.

AI/ML Overview

The provided 510(k) summary for the GE Healthcare LOGIQ P5 BT11 Ultrasound System (K101878) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a premarket notification for a new device, asserting substantial equivalence to previously cleared predicate devices. The focus of this type of submission is to demonstrate that the new device is as safe and effective as existing legally marketed devices, rather than proving performance against specific acceptance criteria through a clinical validation study.

Here's a breakdown of why the requested information is not present and what the document does provide:

Key Takeaways from the Document:

Substantial Equivalence: The primary assertion is that the LOGIQ P5 BT11 employs the "same fundamental scientific technology as its predicate devices" (K060993 LOGIQ P5/A5 Ultrasound System and K092271 LOGIQ E9 Ultrasound System). This is the basis for its clearance, not individual performance metrics against acceptance criteria.
No Clinical Studies Required: The document explicitly states: "The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence." This means there would be no data from a clinical trial to report for acceptance criteria.
Non-Clinical Tests: The device underwent non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are safety and performance standards, but not typically reported as specific acceptance criteria with performance data in this type of summary.
Quality Assurance Measures: The document lists general quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing, safety testing). These are internal processes to ensure quality, not external validation studies with specific performance metrics.
Indications for Use: The document clearly outlines the intended uses and clinical applications for the system and its various transducers (e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular). This defines the scope of the device but doesn't quantify its performance within those applications.

Addressing the Specific Questions (based on the provided document):

A table of acceptance criteria and the reported device performance:
- N/A. This document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No clinical test set or data provenance is mentioned as no clinical studies were required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth establishment for a test set is discussed as no clinical studies were performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method is described.
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:
- N/A. This document predates widespread AI in medical devices and is for an ultrasound system, not an AI-powered diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware-based ultrasound system, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth is discussed as no clinical studies were performed.
The sample size for the training set:
- N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context it's usually used for such applications.
How the ground truth for the training set was established:
- N/A. Not applicable, as it's not an AI/machine learning device.

In summary, this 510(k) submission primarily focuses on demonstrating that the LOGIQ P5 BT11 Ultrasound System is substantially equivalent to existing, legally marketed predicate devices, thereby not requiring new clinical performance studies or the establishment of new acceptance criteria for efficacy.

Summary

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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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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and surrounded by a circular pattern. The logo is black and white and appears to be a vintage or older version of the GE logo.

(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.

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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).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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:

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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse	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-skeletalConventional	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletalSuperficial	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]
IntraoperativeNeurological	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

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

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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]	P	P	P		P	P	P	P	P	P
IntraoperativeNeurological	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

(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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Combined HarmonicModes*	HarmonicImaging	CodedPulse	Other**
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletalSuperficial
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]
IntraoperativeNeurological
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

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

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

. .

510K

Prescription User (Per 21 CFR 801.109)

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

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

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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Otherf4	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperativel5)
IntraoperativeNeurological
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)

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

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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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Combined HarmonicModes*	HarmonicImaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
IntraoperativeNeurological
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

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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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes'	HarmonicImaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
IntraoperativeNeurological
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

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

Prescription User (Per 21 CFR 801.109)

OIC

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510K

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

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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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Combined HarmonicModes*	Imaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
IntraoperativeNeurological
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

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Concurrence of CDRH, GME of Desice Bruitiation (ABE

Prescription User (Per 21 CFR 801.109)

OIVO

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510K

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

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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 ofInterest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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-skeletalConventional
Musculo-skeletalSuperficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[5]
IntraoperativeNeurological
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

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Division of Radiological Devices

. Office of In Vitro Diagnostic Device Evaluation and Safety

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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.