LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Cardiac, Transrectal, and Tissue Biopsy/Fluid Drainage,

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Device Description

The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are entry level ultrasound scanners from the LOGIQ family for private clinics focusing on OB/GYN. The systems are for general purpose imaging and analysis providing real-time digital acquisition, processing and display capability intended for general radiology imaging, evaluation with some cardiology and vascular applications, and providing guidance during tissue biopsy and fluid drainage procedures. The track 3 systems consist of a mobile console with keyboard control panel; color display and optional image storage, wireless capability, and printing devices. They utilize a variety of linear, curved linear and matrix phased array transducers. The systems have the same hardware and software but may have different options available.

AI/ML Overview

The document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics LLC LOGIQ V5 Expert, LOGIQ V5, and LOGIQ V3 ultrasound systems.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 systems comply with several voluntary standards for safety and performance. These standards serve as the acceptance criteria for the device. The reported device performance is that the systems meet these standards.

Acceptance Criteria (Standards)	Reported Device Performance
AAMI/ANSI ES 60601-1 (Medical Electrical Equipment - General Requirements for Safety, 2005)	Conforms to standard
IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: Electromagnetic Compatibility Requirements and Tests, 2007)	Conforms to standard
IEC 60601-2-37 (Medical Electrical Equipment Part 2-37: Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007)	Conforms to standard
NEMA UD 3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004)	Acoustic power levels below applicable FDA limits
ISO 10993-1 (Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing, 2009)	Transducer and patient contact materials are biocompatible
NEMA UD 2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004)	Conforms to standard
ISO 14971 (Application of risk management to medical devices, 2007)	Risk analysis applied during development
NEMA, PS 3.1 3.20 (2011) (Digital Imaging and Communications in Medicine (DICOM) Set)	Conforms to standard

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "The subject of this premarket submission, LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3, did not require clinical studies to support substantial equivalence." This indicates that there was no specific clinical "test set" in the traditional sense, and therefore no associated sample size or data provenance from clinical testing for this specific submission. The majority of the comparisons are based on predicate devices and compliance with recognized standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

As no clinical studies were required, there were no experts used to establish ground truth for a clinical test set in this submission. The "ground truth" for demonstrating substantial equivalence relied on compliance with engineering and safety standards, and comparison to already cleared predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document explicitly states that clinical studies were not required. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and compliance with standards, not comparative effectiveness with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This device is an ultrasound imaging system, which inherently involves a human operator (sonographer/clinician) to acquire and interpret the images. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in the context of this device. The performance is tied to the integrated system and its ability to produce diagnostic quality images for human interpretation.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence in this submission is primarily based on:

Compliance with recognized industry standards: (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, NEMA, PS 3.1 3.20).
Technical comparison to predicate devices: Proving that the new device has the same or similar intended use, technology, probes, and performance as devices already cleared by the FDA.

8. Sample Size for the Training Set:

Not applicable. This is a medical imaging device, not an AI/ML algorithm that requires a "training set" in the context of data-driven learning. The development process involved traditional engineering design, testing, and verification against specifications and standards.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this type of device. The verification and validation process involved:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use Testing (Validation)

These measures aim to ensure the device performs according to its specifications and meets safety and efficacy requirements, derived from established engineering principles and regulatory standards.

Summary

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

August 5, 2016

GE Medical Systems Ultrasound and Primary Care Diagnostics LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K161224

Trade/Device Name: LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 Regulation Number: 21CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 30, 2016 Received: July 5, 2016

Dear Ms. Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161224

Device Name LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 Ultrasound System

	Mode of Operation
Clinical Application	B	M	Doppler Modes					CombinedModes*	HarmonicImaging	CodedPulse•	Other
Anatomy/Region of Interest			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics[1]	P	P	P	P	P		P	P	P	P	[5]
Abdominal[1]	P	P	P	P	P		P	P	P	P	[5]
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P		P	P	P	P
Neonatal Cephalic	P	P	P	P	P		P	P	P	P
Adult Cephalic	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
Musculo-skeletal Conventional	P	P	P	P	P		P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P		P	P	P	P
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	P	P	P	P	P		P	P	P	P
Transesophageal
Transrectal	N	N	N		N		N	N	N
Transvaginal	P	P	P		P		P	P	P
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage [4]	N	N	N	N	N		N	N	N		[5]
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;
[5] 3D/4D imaging Mode;
[*]Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame is decorated with ornamental flourishes, giving it a classic and elegant appearance. The logo is colored in blue, set against a white background.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with 4C-RS Transducer

	Mode of Operation
Clinical Application	B	M	Doppler Modes					CombinedModes *	HarmonicImaging	CodedPulse`	Other
			PW	CW	Color	Color M	Power
Anatomy/Region of Interest
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	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2
Vascular Access (IV, PICC)
Nerve Block
Other

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA 141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The color of the letters and the frame is blue, and the background is white. The logo is simple and recognizable, representing the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with 8C-RS Transducer

	Mode of Operation
Clinical Application	B	M	Doppler Modes			CombinedModes*	HarmonicImaging	CodedPulse	Other
			PW	CW	Color	Color M	Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	p3	p3	p3			p3		p3	p3	p3
Small Organ [2]
Neonatal Cephalic	p3	p3	p3			p3		p3	p3	p3
Adult Cephalic
Cardiac[3]	p3	p3	p3			p3		p3	p3	p3
Peripheral Vascular
Musculo-skeletal Conventional	p3	p3	p3			p3		p3	p3	p3
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. There are three small, white, curved shapes around the inside of the circle, evenly spaced.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with 3Sc-RS Transducer

	Mode of Operation
Clinical Application	B	M	Doppler Modes					CombinedModes*	HarmonicImaging	CodedPulse`	Other
			PW	CW	Color	Color M	Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P		P	P	P
Cardiac [3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	P	P	P	P	P		P	P	P
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P2	P2	P2	P2	P2		P2	P2	P2
Vascular Access (IV, PICC)
Nerve Block
Other

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that features decorative flourishes or embellishments around the perimeter. The color of the logo is blue.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with L6-12-RS Transducer

Clinical Application	B	M	Mode of Operation					Other
			PW	CW	Color	Color M	Power	CombinedModes *	HarmonicImaging	CodedPulse`
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P		P		P	P	P
Small Organ [2]	P	P	P		P		P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P		P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	p2	p2	p2		p2		p2	p2	p2
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three small, white, curved shapes around the inside of the circle, evenly spaced apart.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with E8C-RS Transducer

Clinical Application			Mode of Operation
	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse'	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P
Abdominal[1]	P	P	P		P		P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	P2	p2	P2		p2		P2	P2	P2
Transvaginal	P	P	P		P		P	P	P
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage [4]	p2	p2	P2		p2		P2	P2	P2
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The letters are white and are surrounded by a blue background. The circle is bordered by a white line.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with RAB2-6-RS Transducer

Clinical Application	B	M	Doppler Modes					CombinedModes	HarmonicImaging	Other
Anatomy/Region of Interest			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics	p2	p2	p2		p2		p2	p2	p2	[5]
Abdominal[1]	p2	p2	p2		p2		p2	p2	p2	[5]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	p2	p2	p2		p2	p2	p2	p2	p2	[5]
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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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" in a stylized, cursive font, enclosed within a circular frame. The frame is decorated with ornamental flourishes, giving it a classic and elegant appearance. The logo is colored in blue, set against a white background.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with 6S-RS Transducer

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes *	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	p2	p2	p2		p2		p2	p2	p2
Small Organ [2]
Neonatal Cephalic	p3	p3	p3	p3	p3		p3	p3	p3
Adult Cephalic
Cardiac[3]	p2	p2	p2	p2	p2	p2	p2	p2	p2
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	p2	p2	p2	p2	p2		p2	p2	p2
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

[*]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)

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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame is decorated with ornamental flourishes, giving it a classic and elegant appearance. The logo is colored in blue, set against a white background.

Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with E8Cs-RS Transducer

Clinical Application	B	M	Mode of Operation
			PW	CW	Color	Color M	Power	CombinedModes	HarmonicImaging	CodedPulse
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P2	P2	P2		P2		P2	P2	P2
Abdominal[1]	P2	P2	P2		P2		P2	P2	P2
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	P2	P2	P2		P2		P2	P2	P2
Transvaginal	P2	P2	P2		P2		P2	P2	P2
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage [4]	P2	P2	P2		P2		P2	P2	P2
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K160277;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

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

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Diagnostic Ultrasound Indications for Use Form LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 with 12L-RS Transducer

Clinical Application	B	M	Doppler Modes						CombinedModes	HarmonicImaging
Anatomy/Region of Interest			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics
Abdominal1
Pediatric	p3	p3	p3		p3		p3	p3	p3	p3
Small Organ [2]	p3	p3	p3		p3		p3	p3	p3	p3
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	p3	p3	p3		p3		p3	p3	p3	p3
Musculo-skeletal Conventional	p3	p3	p3		p3		p3	p3	p3	p3
Musculo-skeletal Superficial	p3	p3	p3		p3		p3	p3	p3	p3
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	p3	p3	p3		p3		p3	p3	p3	p3
Vascular Access (IV, PICC)
Nerve Block

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K141768; P2= previously cleared by FDA K1602777;

P3= previously cleared by FDA K151028

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;

[5] 3D/4D imaging Mode;

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

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510(k) Summarv

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: April 28, 2016 GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226 Tracey Ortiz Primary Contact Person: Regulatory Affairs Director GE Healthcare T:(262)676-6120 F:(414)918-8275 Secondary Contact Person: Jian Xie Regulatory Affairs GE Medical Systems (China) Co, Ltd. T: +86 510 8527 8651 F: +86 510 8522 7347 LOGIO V5 Expert / LOGIO V5 / LOGIO V3 Device: Trade Name: Common/Usual Name: Ultrasound system Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate LOGIQ V3 / LOGIQ V5 - K141768 Device(s): Reference Predicate LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 - K160277 LOGIO e - K151028 Device(s): The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are entry level Device Description: ultrasound scanners from the LOGIQ family for private clinics focusing on OB/GYN. The systems are for general purpose imaging and analysis providing real-time digital acquisition, processing and display capability intended for general radiology imaging, evaluation with some cardiology and vascular applications, and providing guidance during tissue biopsy and fluid drainage procedures.

The track 3 systems consist of a mobile console with keyboard control panel; color display and optional image storage, wireless

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capability, and printing devices. They utilize a variety of linear, curved linear and matrix phased array transducers. The systems have the same hardware and software but may have different options available.

Intended Use: The LOGIO V5 Expert / LOGIO V5 / LOGIO V3 are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Urological, Cardiac, Transrectal, and Tissue Biopsy/Fluid Drainage
Technology: The LOGIO V5 Expert / LOGIO V5 / LOGIO V3 employ the same fundamental scientific technology as its predicate devices.

Comparison to Predicates Determination of Substantial Equivalence:

The following is an overview of the difference between the proposed LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 and the predicate LOGIQ V5 / LOGIQ V3 (K141768). Most of feartures and probes are currently cleared on other GE ultrousund systems.

The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The proposed LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 and the predicate LOGIQ V5 / LOGIQ V3 have the same intended use and clincial applications except the addition of the transrectal and biopsy applications that were cleared on the LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 predicate (K160277).
The proposed LOGIO V5 Expert / LOGIO V5 / LOGIO ● V3 and the predicate LOGIQ V5 / LOGIQ V3 have the same probes except for 5 being added: 6S-RS, E8Cs-RS, and RAB2-6-RS were cleared in predicate the LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 predicate (K160277); 12L-RS and 8C-RS were cleared in predicate LOGIQ e system (K151028).
The 6S-RS probe application is being expanded to include ● Neonatal Cephalic which was cleared in the LOGIO e predicate system (K151028).

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510(k) Premarket Notification Submission

Adding a 3D/4D mode with the RAB2-6-RS probe that was cleared on the predicate LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 (K160277).
. A USB wireless adaptor is being added to allow for wireless connectivity like that in predicate LOGIQ e (K151028).
Adding optional LCD monitor display sizes and a VGA/S-video/composite output.
Expanding the Scan Coach software feature
Adding 3D/4D imaging which was cleared in predicate ● device LOGIQ F8 Expert/LOGIQ F8/LOGIQ F6 (K160277).
The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 and the predicate LOGIQ V5 / LOGIQ V3 have been designed in compliance with electrical and physical safety standards.
. The LOGIO V5 Expert / LOGIO V5 / LOGIO V3 and the predicate LOGIQ V5 / LOGIQ V3 have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The system has acoustic power levels which are below the ● applicable FDA limits.

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 to applicable medical device safety standards. The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 and its applications comply with voluntary standards:

AAMI/ANSI ES 60601-1, Medical Electrical Equipment ● - Part 1: General Requirements for Safety, 2005
IEC 60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
IEC 60601-2-37, Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic

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510(k) Premarket Notification Submission

Medical Diagnostic and Monitoring Equipment, 2007

NEMA UD 3, Standard for Real Time Display of Thermal ● and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
. ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing, 2009
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004
ISO 14971, Application of risk management to medical ● devices, 2007
NEMA, PS 3.1 3.20 (2011), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)

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)
Performance testing (Verification)
Safety testing (Verification) ●
Simulated use Testing (Validation) ●

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ V5 Expert / LOGIO V5 / LOGIO V3. did not require clinical studies to support substantial equivalence.

GE Healthcare considers the proposed LOGIQ V5 Expert / Conclusion: LOGIO V5 / LOGIO V3 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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.