Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging and processing capabilities without mentioning AI or ML.

Therapeutic

No
The device is described as an "ultrasound imaging and analysis system" for "digital acquisition, processing and display capability" and "general purpose imaging." Its intended use is for "ultrasound imaging, measurement and analysis of the human body." There is no mention of therapeutic applications or interventions.

Diagnostic

Yes
The device is described as "general purposed ultrasound imaging and analysis systems" for various clinical applications, including "Ultrasound imaging, measurement and analysis of the human body." It's used for "general radiology imaging, evaluation," which implies the gathering of information to aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console with keyboard control panel; color display and optional image storage, wireless capability, and printing devices" and utilizes "a variety of linear, curved linear and matrix phased array transducers," indicating it is a hardware system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are ultrasound imaging and analysis systems. They use ultrasound waves to create images of the inside of the human body.
Intended Use: The intended use is for "Ultrasound imaging, measurement and analysis of the human body." This involves directly imaging the patient, not analyzing samples taken from the patient.
Anatomical Sites: The listed anatomical sites are all parts of the human body that are imaged directly with ultrasound.

Therefore, since the device operates by imaging the human body directly using ultrasound and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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:

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

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler imaging system

Anatomical Site

Abdominal, Obstetrical, Gynecological, Small parts, Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Cardiac, Transrectal, and Tissue Biopsy/Fluid Drainage.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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

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

Not Found

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

K141768

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

K160277, K151028

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.

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.

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.

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

2

Indications for Use

510(k) Number (if known) K161224

Device Name LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3

Indications for Use (Describe)

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,

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.

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."

3

Image /page/3/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, matching the color of the circle.

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

	Mode of Operation
Clinical Application	B	M	Doppler Modes					Combined
Modes*	Harmonic
Imaging	Coded
Pulse•	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/Fluid
Drainage [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

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

4

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					Combined
Modes *	Harmonic
Imaging	Coded
Pulse`	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/Fluid
Drainage[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)

5

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			Combined
Modes*	Harmonic
Imaging	Coded
Pulse	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/Fluid
Drainage[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)

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 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					Combined
Modes*	Harmonic
Imaging	Coded
Pulse`	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/Fluid
Drainage[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)

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, 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	Combined
Modes *	Harmonic
Imaging	Coded
Pulse`
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/Fluid
Drainage[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)

8

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	Combined
Modes*	Harmonic
Imaging	Coded
Pulse'	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/Fluid
Drainage [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)

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 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 Modes | Harmonic
Imaging | Coded
Pulse | 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 | Musculo-skeletal Superficial | Thoracic/Pleural | Other | Exam Type, Means of Access | Transcranial | Transesophageal | Transrectal | Transvaginal | Intraoperative | Interventional Guidance | Tissue Biopsy/Fluid
Drainage[4] | p2 | p2 | p2 | Vascular Access (IV, PICC) | Nerve Block | B | M | Doppler Modes | | | | | Combined
-------|----|----|---------------|----|-------|---------|-------|-------------------|---------------------|----------------|-------|
| | | PW | CW | Color | Color M | Power | | | | |
| | | | | | | | | | | |
| p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | | [5] |
| p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | | [5] |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | p2 | p2 | p2 | p2 | p2 | | [5] |
| | | | | | | | | | | |
| | | | | | | | | | | |

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)

10

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	Combined
Modes *	Harmonic
Imaging	Coded
Pulse	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/Fluid
Drainage[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)

11

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	Combined
Modes	Harmonic
Imaging	Coded
Pulse
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/Fluid
Drainage [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)

12

Image /page/12/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 12L-RS Transducer

| Clinical Application | B | M | Doppler Modes | | | | | | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
|------------------------------------|----|----|---------------|----|-------|---------|-------|----|-------------------|---------------------|----------------|-------|
| 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/Fluid
Drainage[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

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

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 border. The logo is blue and white.

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

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The logo is colored in blue, with a white outline around the letters and the circular border.

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).

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. The letters are surrounded by a circular border with wave-like designs around the perimeter. The logo is colored in a light blue hue.

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

16

Image /page/16/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, and there are decorative swirls or flourishes around the circle, giving it a classic and recognizable appearance. The logo is presented in a blue color.

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.