Ge Medical Systems, LLC - FDA 510(k) Cleared Devices
Recent clearances: Enhanced Boundary for PCCT, Critical Care Suite with Enteric Tube Positioning AI Algorithm, Photonova Spectra, Photonova Spectra Select
105
Total
105
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ge Medical Systems, LLC Radiology ✕
105 devices
Cleared
Jun 24, 2026
Enhanced Boundary for PCCT
Radiology
219d
Cleared
Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
Radiology
166d
Cleared
Mar 20, 2026
Photonova Spectra, Photonova Spectra Select
Radiology
128d
Cleared
Feb 06, 2026
SIGNA™ Bolt
Radiology
72d
Cleared
Feb 05, 2026
SIGNA™ Sprint Select
Radiology
71d
Cleared
Dec 23, 2025
AIR Recon DL
Radiology
146d
Cleared
Sep 11, 2025
SIGNA™ Sprint
Radiology
128d
Cleared
Aug 01, 2025
Revolution Vibe
Radiology
126d
Cleared
Jun 05, 2025
Sonic DL
Radiology
190d
Cleared
Mar 17, 2025
SIGNA Prime Elite
Radiology
34d
Cleared
Oct 17, 2024
SIGNA MAGNUS
Radiology
167d
Cleared
Apr 02, 2024
ECG-less Cardiac
Radiology
132d
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