LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
Device Facts
| Record ID | K160277 |
|---|---|
| Device Name | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Mar 25, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
The LOGIQ F8 Expert/F8/F6 are mobile, console-based diagnostic ultrasound systems. They acquire, process, and display digital ultrasound images for clinical diagnosis. The system includes a console, keyboard, touch panel, and 17-19 inch LCD display. It supports various transducers for imaging modes including B-mode, M-mode, PW/CW Doppler, Color Flow, Power Doppler, and 3D/4D imaging. Used in clinical settings by physicians and sonographers, the device provides real-time visualization and quantitative analysis (e.g., Auto-EF, Sonobiometry). Output is displayed on the integrated monitor for clinical decision-making, aiding in diagnosis across multiple anatomical regions. The system supports wireless connectivity and DICOM standards for data management.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/UD 3, and ISO 10993-1.
Technological Characteristics
Mobile console-based ultrasound system (1600mm x 810mm x 720mm). Employs pulsed Doppler, echo imaging, and transducer technology. Connectivity via DICOM (NEMA PS 3.1-3.20). Biocompatible patient-contact materials per ISO 10993-1. Safety compliance: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37. Features include 3D/4D imaging, elastography, and coded pulse for harmonics.
Indications for Use
Indicated for ultrasound imaging, measurement, and analysis of the human body for abdominal, obstetrical, gynecological, small parts, vascular/peripheral vascular, transcranial, pediatric, musculoskeletal, urological, and cardiac applications, including transvaginal, transrectal, and biopsy procedures.
Regulatory Classification
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.
Predicate Devices
- LOGIQ F Series (K133034)
- LOGIQ S7 (K141261)
- Venue 50 (K152758)
- LOGIQ V3 / LOGIQ V5 (K141768)
- LOGIQ e (K151028)
Related Devices
- K133034 — LOGIQ F SERIES · GE Healthcare · Jan 31, 2014
- K160182 — LOGIQ S7 Expert · GE Healthcare · Feb 26, 2016
- K152195 — LOGIQ S8 · GE Healthcare · Sep 29, 2015
- K111582 — LOGIQ S8 · GE Healthcare · Jul 26, 2011
- K032974 — GE LOGIQ 5 PRO OR EXPERT · General Electric Co. · Oct 21, 2003
Submission Summary (Full Text)
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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 an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
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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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:
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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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Image /page/5/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 circle. The letters are white, creating a contrast against the blue background. The logo is simple and recognizable, representing the well-known multinational conglomerate.
### 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<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular border. The letters and the border are in a light blue color, set against a white background.
# 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<br>Modes | Harmonic<br>Imaging | Coded<br>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<br>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)
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a circular border. The letters and the border are in a light blue color, set against a white background.
# Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 8C-RS Transducer
| Clinical Application | B | M | Mode of Operation<br>Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse' | Other |
|----------------------------------|----|----|------------------------------------|----|-------|---------|-------|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal1 | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ2 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac3 | P | P | P | | P | | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P3 | 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<br>Drainage4 | | | | | | | | | | | |
| 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/8/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 3Sc-RS Transducer
| | Mode of Operation | | | | | | | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|-----------------------------------|-------------------|---|----|----|-------|---------|-------|-------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | P | P | P | | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/9/Picture/0 description: The image shows the 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 L6-12-RS Transducer
| | Mode of Operation | | | | | | | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|-----------------------------------|-------------------|---|----|----|-------|---------|-------|---------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' 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 E8C-RS Transducer
| | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|----|---------------|----|-------|---------|-------|-------------------|---------------------|----------------|-------|
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| | | | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P3 | P3 | P3 | | P3 | | P3 | P3 | P3 | | |
| Transvaginal | P | P | P | | P | | P | P | P | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>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)
{11}------------------------------------------------
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<br>Modes* | Harmonic<br>Imaging | Coded<br>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)
{12}------------------------------------------------
Image /page/12/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 circular border. The letters and the border are in a light blue color, set against a white background.
### Diagnostic Ultrasound Indications for Use Form LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 with 6S-RS Transducer
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|----|----|-------|---------|-------|---------------------|---------------------|----------------|-------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes * | Harmonic<br>Imaging | Coded<br>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<br>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<br>Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>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<br>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)
{14}------------------------------------------------
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<br>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)
{15}------------------------------------------------
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<br>PW | CW | Color | Color M | Power | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>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:<br>Submitter: | January 29, 2016<br>GE Medical Systems Ultrasound and Primary Care Diagnostics,<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262)676-6120<br>F:(414)918-8275 |
| Secondary Contact Person: | Jian Xie<br>Regulatory Affairs<br>GE Medical Systems (China) Co, Ltd.<br>T: +86 510 8527 8651<br>F: +86 510 8522 7347 |
| Device:<br>Trade Name:<br>Common/Usual Name:<br>Classification Names: | LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6<br>Ultrasound system<br>Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | LOGIQ F Series - K133034<br>LOGIQ S7 – K141261 Venue 50 - K152758<br>LOGIQ V3 / LOGIQ V5 -K141768<br>LOGIQ e-K151028 |
| Device Description: | The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general<br>purpose diagnostic ultrasound systems which consists of a mobile<br>console approximately 1600mm high, 810mm in width and<br>720mm deep that provides digital acquisition, processing and<br>display capability. The user interface includes a computer<br>keyboard, 19 or 17 inch color LCD display and Touch panel.<br>LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 have the same<br>hardware and system features. |
{17}------------------------------------------------
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 Pr…
