Data / Medical devices / Israel / GE Medical Systems, Israel Ltd.
GE Medical Systems, Israel Ltd.: FDA-registered device maker in Haifa, Israel, 16 510(k) clearances
GE Medical Systems, Israel Ltd. is registered with the FDA (registration 9615849) in Haifa, Israel. It lists 5 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 7, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615849
- FEI number
- 3002973981
- Address
- Nativ Ha'or Street no. 1, Haifa, Israel, 3508510
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- October 13, 2014
- Registered through
- 2027
- Brand names listed
- 11L-D, 12L-RS, 12S-D, 12S-RS, 3Sc-RS, 4Sc-RS, 6S-D, 6S-RS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | accessdata.fda.gov |
| Twister, Brace Setting | ITO | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2026 | K261668 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| July 25, 2025 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240206 | Venue Sprint | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240111 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240053 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K234106 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 27, 2022 | K220851 | Venue | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 27, 2022 | K220848 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 21, 2022 | K220800 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 29, 2020 | K203137 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 18, 2020 | K202233 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 13, 2020 | K202132 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 28, 2019 | K183362 | Venue GO | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 2, 2018 | K180599 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 21, 2017 | K170714 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| October 10, 2014 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Ge Medical Systems Israel , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 6, 2023 | 93069 | Class II | Ongoing | Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system | Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of Twister, Brace Setting
Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.