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GE Healthcare FDA Approvals
1 new drug approval and 16 device clearances on file. Matched by name to GEHC.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| View510(k)Jan 8, 2026Radiology |
| MR Contour DL510(k)Apr 1, 2025Radiology |
| REGADENOSONNew drugAug 5, 2024SOLUTION, INTRAVENOUS |
| Digital Expert Access with Remote Scanning510(k)Oct 27, 2023Radiology |
| Precision DL510(k)Apr 27, 2023Radiology |
| Xeleris V Processing and Review System510(k)Mar 1, 2023Radiology |
| Omni Legend510(k)Sep 2, 2022Radiology |
| Voluson P6, Voluson P8510(k)Feb 17, 2022Radiology |
| Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert510(k)Jan 13, 2022Radiology |
| LOGIQ E10510(k)Sep 10, 2021Radiology |
| LOGIQ E10s, LOGIQ Fortis510(k)Aug 27, 2021Radiology |
| MyoSPECT, MyoSpect ES510(k)Aug 27, 2021Radiology |
| Senographe Pristina510(k)Aug 6, 2021Radiology |
| SenoBright HD510(k)Jun 22, 2021Radiology |
| Universal Viewer510(k)May 21, 2021Radiology |
| StarGuide510(k)Mar 29, 2021Radiology |
| Panda iRes Warmer, Giraffe Warmer510(k)Feb 12, 2021General Hospital |