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Ge Medical Systems, LLC FDA Approvals
0 new drug approvals and 23 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Enhanced Boundary for PCCT510(k)Jun 24, 2026Radiology |
| Critical Care Suite with Enteric Tube Positioning AI Algorithm510(k)Apr 14, 2026Radiology |
| Photonova Spectra, Photonova Spectra Select510(k)Mar 20, 2026Radiology |
| SIGNA Bolt510(k)Feb 6, 2026Radiology |
| SIGNA Sprint Select510(k)Feb 5, 2026Radiology |
| AIR Recon DL510(k)Dec 23, 2025Radiology |
| SIGNA Sprint510(k)Sep 11, 2025Radiology |
| Revolution Vibe510(k)Aug 1, 2025Radiology |
| Sonic DL510(k)Jun 5, 2025Radiology |
| SIGNA Prime Elite510(k)Mar 17, 2025Radiology |
| SIGNA MAGNUS510(k)Oct 17, 2024Radiology |
| ECG-less Cardiac510(k)Apr 2, 2024Radiology |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite510(k)May 25, 2023Radiology |
| Auto Segmentation510(k)May 4, 2023Radiology |
| Spectral Bone Marrow510(k)Mar 9, 2023Radiology |
| Deep Learning Image Reconstruction510(k)Feb 18, 2022Radiology |
| SIGNA PET/MR510(k)Jan 20, 2022Radiology |
| Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition510(k)Dec 17, 2021Radiology |
| Critical Care Suite with Endotracheal Tube Positing AI algorithm510(k)Oct 29, 2021Radiology |
| Discovery MI Gen2510(k)Aug 20, 2021Radiology |
| SIGNA 7.0T510(k)May 13, 2021Radiology |
| AMX Navigate510(k)Apr 28, 2021Radiology |
| MaxFOV 2510(k)Mar 2, 2021Radiology |