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Ge Medical Systems, LLC

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories9
Latest FDA decision2026-06-24
TypeNumberDevice NameCodeDateActions
510(k) K253560 Enhanced Boundary for PCCTJAK2026-06-24 View
510(k) K253502 Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH2026-04-14 View
510(k) K253520 Photonova Spectra, Photonova Spectra SelectJAK2026-03-20 View
510(k) K253780 SIGNA™ BoltLNH2026-02-06 View
510(k) K253779 SIGNA™ Sprint SelectLNH2026-02-05 View
510(k) K252379 AIR Recon DLLNH2025-12-23 View
510(k) K251399 SIGNA™ SprintLNH2025-09-11 View
510(k) K250941 Revolution VibeJAK2025-08-01 View
510(k) K243667 Sonic DLLNH2025-06-05 View
510(k) K250379 SIGNA Prime EliteLNH2025-03-17 View
510(k) K241242 SIGNA MAGNUSLNH2024-10-17 View
510(k) K233750 ECG-less CardiacJAK2024-04-02 View
510(k) K223491 Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteQBS2023-05-25 View
510(k) K230082 Auto SegmentationQKB2023-05-04 View
510(k) K223514 Spectral Bone MarrowJAK2023-03-09 View
510(k) K213999 Deep Learning Image ReconstructionJAK2022-02-18 View
510(k) K213709 SIGNA PET/MROUO2022-01-20 View
510(k) K213715 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 editionJAK2021-12-17 View
510(k) K211161 Critical Care Suite with Endotracheal Tube Positing AI algorithmQIH2021-10-29 View
510(k) K211846 Discovery MI Gen2KPS2021-08-20 View

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