LOGIQ V1/ LOGIQ V2 by GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC

The LOGIQ V ! / LOGIQ V2 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).

Device Description

The LOGIQ V1 / LOGIQ V2 systems are a laptop ultrasound console approximately 120mm in height, 368mm in width and 396mm in length with integrated keyboard, a color video LCD type display, one inbuilt active probe ports and two probe port adapters. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger. LOGIQ V1 and LOGIQ V2 have the same hardware and system features.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for GE Medical Systems' LOGIQ V1/LOGIQ V2 ultrasound systems. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and testing methodology for a novel AI/CAD device.

Therefore, the specific information requested regarding acceptance criteria, device performance data, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this document.

The document states:
"Summary of Clinical Tests: The subject of this premarket submission, LOGIQ V1 / LOGIQ V2, did not require clinical studies to support substantial equivalence." (page 15)

This indicates that a performance study with the requested details was not conducted or submitted for this particular FDA clearance, as the device was deemed substantially equivalent to predicates based on technological characteristics and safety standards.

The document lists the product as an "Ultrasonic pulsed doppler imaging system" (21 CFR 892.1550). It's a general-purpose ultrasound system (hardware), not specifically an AI or CAD device with performance metrics based on diagnostic accuracy.

Given the information provided, I cannot populate the table or answer the specific questions about acceptance criteria and study details.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.

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

January 4, 2016

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

Re: K153037

Trade/Device Name: LOGIQ V1/ LOGIQ V2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 22, 2015 Received: December 23, 2015

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.

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

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,

Robert Oels

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153037

Device Name LOGIQ V1 / LOGIQ V2

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue. The border around the letters has a decorative, swirling pattern.

Diagnostic Ultrasound Indications for Use Form LOGIQ V1 / LOGIQ V2 Ultrasound System

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N	N
Small Organ [2]	N	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	N
Cardiac [3]	N	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	N
Thoracic/Pleural
Other[5]	N	N	N	N	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N	N	N	N
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	N	N	N	N	N	N	N	N	N	N	4
Vascular Access (IV, PICC)	N	N	N	N	N	N	N	N	N	N	4
Nerve Block	N	N	N	N	N	N	N	N	N	N	4

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

N = new indication

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

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

] Coded Pulse is for digitally encoded harmonics.

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

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

Image /page/5/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 circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a slightly darker blue background.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with 4C-RS Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse•	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	P
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P	P
Thoracic/Pleural
Other[5]	P	P	P		P		P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P		P		P	P	P	P	4
Vascular Access (IV, PICC)
Nerve Block	P	P	P		P		P	P	P	P	4

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

N = new indication; P= previously cleared by FDA 151028; P= previously cleared by FDA K141768

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

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

] Coded Pulse is for digitally encoded harmonics.

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

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

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 circular border. The color of the logo is blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with 8C-RS Transducer

		Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse`	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P		P		P	P	P	N
Small Organ [2]
Neonatal Cephalic	P	P	P		P		P	P	P	N
Adult Cephalic
Cardiac [3]	P	P	P		P		P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P		P	P	P	N
Musculo-skeletal Superficial	P	P	P		P		P	P	P	N
Thoracic/Pleural
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage
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 K151028; P= previously cleared by FDA K141768

[1] Abdominal includes GYN and Urological; Notes:

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

[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

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

[*] Coded Pulse is for digitally encoded harmonics.

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

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

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 script, enclosed within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a slightly darker blue background.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with E8C-RS Transducer

Clinical Application	B	M	PWDoppler	ColorDoppler	PDI	CombinedModes*	HarmonicImaging	CodedPulse'	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P1
Abdominal[1]	P	P	P	P	P	P	P	P1
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other[5]	P	P	P	P	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	N
Transvaginal	P	P	P	P	P	P	P	P1
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P	P	P	P	P	N	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 K151028; P = previously cleared by FDA 141768

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics.

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

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

Image /page/8/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 circular border. The color of the logo is blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with 12L-RS Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse'	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P		P		P	P	P	P
Small Organ[2]	P	P	P		P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P	P
Thoracic/Pleural
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P		P		P	P	P	P	4
Vascular Access (IV, PICC)	P	P	P		P		P	P	P	P	4
Nerve Block	P	P	P		P		P	P	P	P	4

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

N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
["] Coded Pulse is for digitally encoded harmonics.

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

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

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 script inside. The circle has a decorative border with small, curved elements around the perimeter. The logo is simple and recognizable, representing the company's brand.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with 3Sc-RS Transducer

Clinical Application	Mode of Operation
Anatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse`	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P		P		P	P	P
Cardiac[3]	P	P	P		P		P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P	P	P		P		P	P	P		4
Vascular Access (IV, PICC)	P	P	P		P		P	P	P		4
Nerve Block

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

N = new indication; P= previously cleared by FDA K151028; P1= previously cleared by FDA K141768

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
["] Coded Pulse is for digitally encoded harmonics.

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

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

Image /page/10/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 circular border. The color of the logo is blue.

Diagnostic Ultrasound Indications for Use Form

LOGIQ V1 / V2 with L6-12-RS Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse'	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P1	P1	P1		P1		P1	P1	P1	P1
Small Organ [2]	P1	P1	P1		P1		P1	P1	P1	P1
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P1	P1	P1		P1		P1	P1	P1	P1
Musculo-skeletal Conventional	P1	P1	P1		P1		P1	P1	P1	P1
Musculo-skeletal Superficial	P1	P1	P1		P1		P1	P1	P1	P1
Thoracic/Pleural
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage	P1	P1	P1		P1		P1	P1	P1	N	4
Vascular Access (IV, PICC)	P1	P1	P1		P1		P1	P1	P1	N	4
Nerve Block	P1	P1	P1		P1		P1	P1	P1	N	4

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

N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768

Notes: [1] Abdominal includes GYN and Urological;

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

[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

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

] Coded Pulse is for digitally encoded harmonics.

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

{11}------------------------------------------------

Image /page/11/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 circular border. The color of the logo is blue.

Diagnostic Ultrasound Indications for Use Form LOGIQ V1 / V2 with LK760-RS Transducer

	Mode of Operation
Clinical Application	B	M	PWDoppler	CWDoppler	ColorDoppler	ColorM	PDI	CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P		P	P	P	N
Musculo-skeletal Superficial	P	P	P		P		P	P	P	N
Thoracic/Pleural
Other[5]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage
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 K151028; P= previously cleared by FDA K141768

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

[4] Includes image guidance for freehand needle placement

[5] Other is Urology and includes Prostate;

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

"] Coded Pulse is for digitally encoded harmonics.

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

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, and there are decorative swirls around the letters within the circle.

510(k) Summary

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

October 16, 2015 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226

Primary Contact Person: Tracey Ortiz
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

Device:	Trade Name: LOGIQ V1 / LOGIQ V2
Common/Usual Name:	Ultrasound system
Classification Names:Product Code:	Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	LOGIQ e - K151028LOGIQ V3 / LOGIQ V5 - K141768
Device Description:	The LOGIQ V1 / LOGIQ V2 systems are a laptop ultrasoundconsole approximately 120mm in height, 368mm in width and396mm in length with integrated keyboard, a color video LCDtype display, one inbuilt active probe ports and two probe portadapters. It has digital acquisition, processing and displaycapability and operates from an integrated battery or separatepower supply/charger. LOGIQ V1 and LOGIQ V2 have the samehardware and system features.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The frame has a swirling design around the letters, and the entire logo is in a light blue color.

The LOGIQ V1 / LOGIQ V2 is intended for ultrasound imaging, Intended Use: measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Urology: Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).
The LOGIQ V1 / LOGIQ V2 employs the same fundamental Technology: scientific technology as its predicate devices.

Determination of Comparison to Predicates

Substantial Equivalence:

The LOGIQ V1 / LOGIQ V2 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.

o The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e have the same intended use and similar clinical applications.
The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e ● system have the same imaging modes.
The system is 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.
The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e system have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e ● system have been designed in compliance with approved electrical and physical safety standards.
The transducer L6-12-RS is cleared in predicate LOGIQ ● V3 / LOGIO V5 (K141768), other transducers are cleared in predicate LOGIQ e system (K151028).

{14}------------------------------------------------

Image /page/14/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 has decorative, swirling elements around the letters. The logo is colored in a light blue hue.

o Software features are the same as is on the predicate LOGIQ e plus Sonobiometry(AFB) and ScanCoach features have been added from predicate LOGIQ V3 / LOGIQ V5 (K141768).

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 V1 / LOGIQ V2 and its applications comply with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety
IEC60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
IEC60601-2-37. Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
ISO14971, Application of risk management to medical ● devices
NEMA, 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) ●

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.

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 V1 / LOGIQ V2, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the LOGIQ V1 / LOGIQ V2 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.