Data / Medical devices / Israel / Ge Medical Systems Israel, Functional Imaging
Ge Medical Systems Israel, Functional Imaging: FDA-registered device maker in Haifa, Israel, 38 510(k) clearances
Ge Medical Systems Israel, Functional Imaging is registered with the FDA (registration 3027338963) in Haifa, Israel. It lists 8 device types. The FDA files 38 510(k) clearances under its listings, the newest dated June 12, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027338963
- Address
- Andrei Sakharov St 9, Haifa, Israel, 3508415
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- April 6, 1994
- Registered through
- 2027
- Brand names listed
- Aurora, Brivo NM 615, Clarify DL, D670 HEAD HOLDER, DaTQUANT, Discovery 670 DR, Discovery Future, Discovery IQ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bed, Scanning, Nuclear | IYZ | 1 | Specification developer | accessdata.fda.gov |
| Camera, Scintillation (Gamma) | IYX | 1 | Specification developer | accessdata.fda.gov |
| Cradle, Patient, Radiologic | KXH | 1 | Specification developer | accessdata.fda.gov |
| Holder, Head, Radiographic | IWY | 1 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | 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 |
|---|---|---|---|---|---|---|
| June 12, 2025 | K251153 | Aurora | KPS | Substantially Equivalent | Ge Medical Systems Israel | accessdata.fda.gov |
| January 17, 2025 | K243605 | Aurora | KPS | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| January 3, 2025 | K241350 | Clarify DL | LLZ | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| August 8, 2024 | K241665 | Omni Legend | KPS | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| April 27, 2023 | K223212 | Precision DL | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 1, 2023 | K221680 | Xeleris V Processing and Review System | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 2, 2022 | K221932 | Omni Legend | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 27, 2021 | K212004 | MyoSPECT, MyoSpect ES | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 20, 2021 | K211846 | Discovery MI Gen2 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 29, 2021 | K210173 | StarGuide | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 25, 2020 | K201103 | Xeleris V Processing and Review Systems | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 17, 2018 | K173816 | NM/CT 850, NM/CT 860 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 11, 2018 | K180318 | PET Digital Gating | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2016 | K160933 | Discovery NM 750b Bopsy | IYX | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 11, 2016 | K161574 | Discovery MI | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 16, 2016 | K153355 | Xeleris 4.0 Processing and Review Workstation | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 21, 2016 | K153402 | Discovery NM/CT 670 CZT | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 18, 2014 | K141477 | DISCOVERY IQ | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 12, 2013 | K130884 | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION | LLZ | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| April 19, 2012 | K121019 | OPTIMA NM/CT 640 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 5, 2011 | K113350 | BRIVO NM 615 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 3, 2011 | K111445 | DISCOVERY NM 630 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 3, 2010 | K102231 | DISCOVERY NM 750B | IYX | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| January 8, 2010 | K093982 | XELERIS 3 PROCESSING AND REVIEW WORKSTATION | LLZ | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| December 10, 2009 | K093514 | DISCOVERY MODEL NM/CT 670 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| December 12, 2008 | K083504 | GE DISCOVERY NM/CT 570C | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 31, 2008 | K080124 | VENTRI 1.1 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| September 27, 2005 | K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| August 2, 2005 | K051855 | VENTRI | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| July 18, 2005 | K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION | LLZ | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| March 17, 2005 | K050559 | GE DISCOVERY VCT SYSTEM | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| January 15, 2003 | K024137 | JUPITER PROCESSING AND REVIEW WORKSTATION | LLZ | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| September 19, 2002 | K022960 | GE QUASAR NUCLEAR MEDICINE SYSTEM | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| August 23, 1999 | K991896 | MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| October 10, 1996 | K962738 | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| July 3, 1995 | K951144 | PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 24, 2025 | 98269 | Class II | Completed | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation). | accessdata.fda.gov |
| September 12, 2025 | 97647 | Class II | Ongoing | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detec | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Scintillation (Gamma)
- All makers of Bed, Scanning, Nuclear
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
- All makers of Holder, Head, Radiographic
Updated January 16, 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.