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24 devices · 3 companies · 2019 to 2026

Ge Medical Systems, LLC: AI-enabled devices on FDA's list

24 devices from Ge Medical Systems, LLC, 2019 to 2026, from 3 companies across 7 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (24 of 24 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Ge Medical Systems, LLC

Every device, newest decision first

Ge Medical Systems, LLC · 24 devices
DecisionDevicePanelProduct codeFDA
Enhanced Boundary for PCCTK253560 · 510(k)RadiologyJAKdatabase entry
Critical Care Suite with Enteric Tube PositioninK253502 · 510(k)RadiologyQIHdatabase entry
Photonova Spectra, Photonova Spectra SelectK253520 · 510(k)RadiologyJAKdatabase entry
SIGNA BoltK253780 · 510(k)RadiologyLNHdatabase entry
SIGNA Sprint SelectK253779 · 510(k)RadiologyLNHdatabase entry
AIR Recon DLK252379 · 510(k)RadiologyLNHdatabase entry
SIGNA SprintK251399 · 510(k)RadiologyLNHdatabase entry
Revolution VibeK250941 · 510(k)RadiologyJAKdatabase entry
Sonic DLK243667 · 510(k)RadiologyLNHdatabase entry
SIGNA Prime EliteK250379 · 510(k)RadiologyLNHdatabase entry
SIGNA MAGNUSK241242 · 510(k)RadiologyLNHdatabase entry
Critical Care Suite with Pneumothorax DetectionK223491 · 510(k)RadiologyQBSdatabase entry
Auto SegmentationK230082 · 510(k)RadiologyQKBdatabase entry
Spectral Bone MarrowK223514 · 510(k)RadiologyJAKdatabase entry
Deep Learning Image ReconstructionK213999 · 510(k)RadiologyJAKdatabase entry
Critical Care Suite with Endotracheal Tube PositK211161 · 510(k)RadiologyQIHdatabase entry
Discovery MI Gen2K211846 · 510(k)RadiologyKPSdatabase entry
SIGNA 7.0TK211118 · 510(k)RadiologyLNHdatabase entry
MaxFOV 2K203617 · 510(k)RadiologyJAKdatabase entry
Deep Learning Image Reconstruction for GemstoneK201745 · 510(k)RadiologyJAKdatabase entry
SIGNA 7.0TK201615 · 510(k)RadiologyLNHdatabase entry
Critical Care SuiteK183182 · 510(k)RadiologyQFMdatabase entry
Deep Learning Image ReconstructionK183202 · 510(k)RadiologyJAKdatabase entry
SIGNA PremierK183231 · 510(k)RadiologyLNHdatabase entry

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