Predicate Devices

LOGIQ F Series - K133034, LOGIQ S7 – K141261, Venue 50 - K152758, LOGIQ V3 / LOGIQ V5 -K141768, LOGIQ e-K151028

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a general-purpose ultrasound system with standard digital image processing capabilities, and there is no mention of AI, ML, or related concepts like deep learning or neural networks.

Therapeutic

No
The device is described as a "general purpose diagnostic ultrasound system" used for "ultrasound imaging, measurement and analysis of the human body," indicating it is used for diagnosis rather than treatment.

Diagnostic

Yes
The "Device Description" explicitly states, "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general purpose diagnostic ultrasound systems." The "Intended Use / Indications for Use" also lists various clinical applications for imaging and analysis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a mobile console with physical dimensions, a keyboard, LCD display, and touch panel, indicating it is a hardware system with integrated software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
Device Description: The description clearly states that the LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are "general purpose diagnostic ultrasound systems." Ultrasound is an imaging modality that uses sound waves to create images of structures inside the living body (in vivo).
Intended Use: The intended use is described as "Ultrasound imaging, measurement and analysis of the human body." This confirms that the device is used for imaging within the body.
Anatomical Sites: The listed anatomical sites (Abdominal, Obstetrical, Gynecological, etc.) are all locations within the human body that are imaged using ultrasound.

The information provided consistently points to this device being an in vivo diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LOGIQ F8 Expert / LOGIQ F6 / LOGIQ F6 are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clincal applications including: Abdominal, Obsterical, Gnall parts, Vascular/Peripheral Vascular, Transcranial, Pediatic, Musculoskeletal, Cardiac, Transvaginal, Transrectal, and Biopsy.

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Transcranial, Pediatric, Musculoskeletal, Urological, Cardiac, Transvaginal, Transrectal, and Biopsy.

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

IYN, IYO, ITX

Device Description

The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general purpose diagnostic ultrasound systems which consists of a mobile console approximately 1600mm high, 810mm in width and 720mm deep that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, 19 or 17 inch color LCD display and Touch panel. LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 have the same hardware and system features.

Mentions image processing

digital acquisition, processing and display capability

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Fetal / Obstetrics, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult and Pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Thoracic/Pleural, Ophthalmic, GYN, Urological/Prostate.

Indicated Patient Age Range

Adult, Pediatric, Neonatal.

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)

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 LOGIO F8 Expert / LOGIO F8 / LOGIO F6 and its applications comply with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005
IEC60601-1-2,Medical Electrical Equipment - Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic 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
ISO10993-1, Biological Evaluation of Medical Devices- Part ● 1: Evaluation and Testing- Third Edition, 2009
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004
ISO14971, Application of risk management to medical devices: Second edition 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)

Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6, 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.

LOGIQ F Series - K133034, LOGIQ S7 – K141261, Venue 50 - K152758, LOGIQ V3 / LOGIQ V5 -K141768, LOGIQ e-K151028

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.

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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

March 25, 2016

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

Re: K160277

Trade/Device Name: LOGIO F8 Expert / LOGIO F8 / LOGIO F6 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2016 Received: February 2, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

Indications for Use

510(k) Number (if Known) -

Device Name LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6

Indications for Use (Describe)

The LOGIQ F8 Expert / LOGIQ F6 / LOGIQ F6 are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clincal applications including: Abdominal, Obsterical, Gnall parts, Vascular/Peripheral Vascular, Transcranial, Pediatic, Musculoskeletal, Cardiac, Transvaginal, Transrectal, and Biopsy.

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)

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)

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740

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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."

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Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 systems and for all of its probe/mode combinations. Combinations identified as "P" represents those previously cleared with another GE Ultrasound system.

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 Ultrasound System

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	P	P	P		P		P	P	P	P	[5]
Abdominal[1]	P	P	P	N	P		P	P	P	P	[5]
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	N	P		P		P	P	P	N	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	N	P		P		P	P	P	N
Musculo-skeletal Conventional	P	N	P		P		P	P	P	N
Musculo-skeletal Superficial	P	N	P		P		P	P	P	N
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	P	P	P	N	P	N	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]	P	P	P	P	P	P	P	P	P	P	[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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

JCombined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

["] Coded Pulse is for digitally encoded harmonics

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 4C-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	P	P	P		P		P	P	P	P
Abdominal[1]	P	N	P		P		P	P	P	P
Pediatric	P	N	P		P		P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P2	P2	P2		P2		P2	P2	P2	P2
Musculo-skeletal Conventional	N	N	N		N		N	N	N	N
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]	P	P			P		P	P	P	P
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

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

[*] Coded Pulse is for digitally encoded harmonics

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 8C-RS Transducer

| Clinical Application Doppler Modes | | | Modes* | Harmonic
Imaging | Coded
Pulse' | Other |
|------------------------------ | Anatomy/Region of Interest | Ophthalmic | Fetal / Obstetrics | Abdominal1 | Pediatric | Small Organ2 | Neonatal Cephalic | Adult Cephalic | Cardiac3 | 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
Drainage4 | | | | Vascular Access (IV, PICC) | Nerve Block | B | M | Mode of Operation
| | Combined
----|----|----|------------------------------------|----|-------|---------|-------|--------------------|---------------------|-----------------|-------|
| | | PW | CW | Color | Color M | Power | | | | |
| | | | | | | | | | | |
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| P | P | P | | P | | P | P | P | P | |
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| P | P | P | | P | | P | P | P | P | |
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| P3 | P3 | P3 | | P3 | | P3 | P3 | P3 | P3 | |
| | | | | | | | | | | |
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Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

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

[*] Coded Pulse is for digitally encoded harmonics

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 3Sc-RS Transducer

| | Mode of Operation | | | | | | | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
|-----------------------------------|-------------------|---|----|----|-------|---------|-------|-------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P3 | P | P | P | P | P | | |
| Pediatric | P | P | P | P3 | P | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | 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] | P | P | P | | P | P | P | P | P | | |
| 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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

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

[D] Coded Pulse is for digitally encoded harmonics

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with L6-12-RS Transducer

| | Mode of Operation | | | | | | | Combined
Modes * | Harmonic
Imaging | Coded
Pulse | Other |
|-----------------------------------|-------------------|---|----|----|-------|---------|-------|---------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | | P | | P | | P | P | P | P2 | |
| Small Organ[2] | P | | P | | P | | P | P | P | P2 | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | | P | | P | | P | P | P | P2 | |
| Musculo-skeletal Conventional | P | | P | | P | | P | P | P | P2 | |
| Musculo-skeletal Superficial | P | | P | | P | | P | P | P | P2 | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | |
| Drainage[4] | P | | P | | P | | P | P | P | | |
| 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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

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

[*] Coded Pulse is for digitally encoded harmonics

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with E8C-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
Abdominal[1]	P3	P3	P3		P3		P3	P3	P3	P3
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	P3	P3	P3		P3		P3	P3	P3
Transvaginal	P	P	P		P		P	P	P
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]	P	P	P		P		P	P	P
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P=previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/11/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 blue circle. There are three curved lines emanating from the circle, giving the impression of movement or energy.

Diagnostic Ultrasound Indications for Use Form

LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with RAB2-6-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	[5]
Abdominal[1]	P	N	P		P		P	P	P	P	[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/Fluid
Drainage[4]	P	P	P		P	P	P	P	P	P	[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 133034; P2= previously cleared by FDA K141768;

P = previously cleared by FDA K151028; P=previously cleared by FDA K152758; P=previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 6S-RS Transducer

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW	CW	Color	Color M	Power	Combined
Modes *	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	p3	p3	p3	p3	p3	p3	p3	p3	p3
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	p3	p3	p3	p3	p3	p3	p3	p3	p3
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	N	N	N	N	N	N	N	N	N
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circular frame. The frame has four small, rounded protrusions evenly spaced around its circumference, giving it a slightly decorative appearance.

Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with L8-18i-RS Transducer

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW	CW	Color	Color M	Power	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]	P3	P3	P3		P3		P3	P3	N
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P3	P3	P3		P3		P3	P3	P3
Musculo-skeletal Conventional
Musculo-skeletal Superficial	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]
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circular frame. The frame has four small, rounded protrusions evenly spaced around its circumference, giving it a slightly decorative appearance.

Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with E8Cs-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	P4	P4	N		P4		P4	P4	P4
Abdominal[1]	P4	P4	N		P4		P4	P4	P4
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	N	N	N		N		N	N	N
Transvaginal	P4	P4	N		P4		P4	P4	P4
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]	P4	P4	N		P4		P4	P4	P4
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P =previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circular frame. The frame has four small, rounded protrusions evenly spaced around its circumference, giving it a slightly decorative appearance.

Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with BE9CS-RS Transducer

	Mode of Operation
Clinical Application	B	M	Doppler Modes
PW	CW	Color	Color M	Power	Combined
Modes	Harmonic
Imaging	Coded
Pulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	p5	p5	p5		p5	p5	p5	p5
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	p5	p5	p5		p5	p5	p5	p5
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]	N	N	N		N	N	N	N
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 133034; P2= previously cleared by FDA K141768;

P= previously cleared by FDA K151028; P=previously cleared by FDA K152758; P=previously cleared by FDA K141261

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

[6] Elastography imaging-Elasticity

[*]Combined modes are B/M, B/ Color 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)

16

Image /page/16/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are swirling designs around the letters. The logo is simple and recognizable.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:
Submitter:	January 29, 2016
GE Medical Systems Ultrasound and Primary Care Diagnostics,
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:
Common/Usual Name:
Classification Names:	LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6
Ultrasound system
Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	LOGIQ F Series - K133034
LOGIQ S7 – K141261 Venue 50 - K152758
LOGIQ V3 / LOGIQ V5 -K141768
LOGIQ e-K151028
Device Description:	The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general
purpose diagnostic ultrasound systems which consists of a mobile
console approximately 1600mm high, 810mm in width and
720mm deep that provides digital acquisition, processing and
display capability. The user interface includes a computer
keyboard, 19 or 17 inch color LCD display and Touch panel.
LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 have the same
hardware and system features.

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Image /page/17/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 decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

Intended Use: The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clinical applications including: Abdominal, Obstetrical, Gynecological, parts. Vascular/Peripheral Vascular, Transcranial. Small Pediatric, Musculoskeletal, Urological, Cardiac, Transvaginal, Transrectal, and Biopsy.
Technology: The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 employ the same fundamental scientific technology as its predicate devices.

Determination of Comparison to Predicates

Substantial Equivalence:

The following is an overview of the difference between the prosed LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series (K133034), The proposed LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 has had serval fearture and probes migrated to it curenlty cleared on other GE ultrousund systems.

o The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same clinical intended use except the addition of the transrectal application that is on the LOGIQ e predicate (K151028).
The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same imaging modes.
The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same probes except for 4 being added: 6S-RS and L8-18i-RS are cleared in predicate LOGIQ e system (K151028); E8Cs-RS has the same transducer as Venue 50 (K152758) with different connector; BE9CS-RS has the same transducer on LOGIQ S7 (K141261) with different connector
The following features have been migrated from LOGIO ● S7 (K141261): Auto-EF, TUI, stress Echo advance 3D and Curved AMM.
The Sonobiometry features has been migrated from predicate LOGIQ V3 / LOGIQ V5 (K141768).
Adding a wireless adaptor to allow for wireless connectivity like that in predicate LOGIQ e K151028
The systems are manufactured with materials which have

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Image /page/18/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 border. There are decorative swirls or flourishes around the outer edge of the circle. The logo is in a light blue color.

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 F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIO F series have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIO F series have been designed in compliance with approved electrical and physical safety standards.

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 LOGIO F8 Expert / LOGIO F8 / LOGIO F6 and its applications comply with voluntary standards:

o AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005
IEC60601-1-2,Medical Electrical Equipment - Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic 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
ISO10993-1, Biological Evaluation of Medical Devices- Part ● 1: Evaluation and Testing- Third Edition, 2009
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004
ISO14971, Application of risk management to medical devices: Second edition 2007
NEMA PS 3.1 3.20 (2011), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)

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Image /page/19/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 border. The space between the letters and the border is filled with a light blue color, while the letters and the border are white. The overall design is simple and recognizable, representing the brand identity of General Electric.

The following quality assurance measures were applied to the development of the system:

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

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).