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Ge Medical Systems, LLC

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42
Categories9
Latest Approval2026-04-14
TypeNumberDevice NameCodeDate
510(k) K253502 Critical Care Suite with Enteric Tube Positioning AI Algorithm QIH 2026-04-14 View
510(k) K253520 Photonova Spectra, Photonova Spectra Select JAK 2026-03-20 View
510(k) K253780 SIGNA™ Bolt LNH 2026-02-06 View
510(k) K253779 SIGNA™ Sprint Select LNH 2026-02-05 View
510(k) K252379 AIR Recon DL LNH 2025-12-23 View
510(k) K251399 SIGNA™ Sprint LNH 2025-09-11 View
510(k) K250941 Revolution Vibe JAK 2025-08-01 View
510(k) K243667 Sonic DL LNH 2025-06-05 View
510(k) K250379 SIGNA Prime Elite LNH 2025-03-17 View
510(k) K241242 SIGNA MAGNUS LNH 2024-10-17 View
510(k) K233750 ECG-less Cardiac JAK 2024-04-02 View
510(k) K223491 Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite QBS 2023-05-25 View
510(k) K230082 Auto Segmentation QKB 2023-05-04 View
510(k) K223514 Spectral Bone Marrow JAK 2023-03-09 View
510(k) K213999 Deep Learning Image Reconstruction JAK 2022-02-18 View
510(k) K213709 SIGNA PET/MR OUO 2022-01-20 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 edition JAK 2021-12-17 View
510(k) K211161 Critical Care Suite with Endotracheal Tube Positing AI algorithm QIH 2021-10-29 View
510(k) K211846 Discovery MI Gen2 KPS 2021-08-20 View
510(k) K211118 SIGNA 7.0T LNH 2021-05-13 View

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