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GE Medical Systems SCS

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories5
Latest FDA decision2026-07-21
TypeNumberDevice NameCodeDateActions
510(k) K253770 CardIQ SuiteJAK2026-07-21 View
510(k) K260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE2026-03-24 View
510(k) K251199 Allia MoveoOWB2025-12-09 View
510(k) K243672 CardIQ SuiteJAK2025-06-18 View
510(k) K243651 VersaViewerLLZ2025-04-21 View
510(k) K243446 3DXROWB2025-02-25 View
510(k) K233731 CardIQ SuiteJAK2024-08-01 View
510(k) K233714 BreViewLLZ2024-01-25 View
510(k) K232344 Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OROWB2023-10-11 View
510(k) K223424 Spine Auto ViewsJAK2023-07-13 View
510(k) K223490 FlightPlan for EmbolizationLLZ2023-03-21 View
510(k) K222895 DynamicIQKPS2022-11-22 View
510(k) K223152 Vision 2, EVARVision, TrackVision 2, HeartVision 2LLZ2022-11-22 View
510(k) K211180 Liver SuiteJAK2022-05-02 View
510(k) K213725 CardIQ SuiteJAK2022-03-11 View
510(k) K210807 FlightPlan for LiverLLZ2021-10-22 View
510(k) K211247 PET VCARKPS2021-07-27 View
510(k) K200626 VesselIQ XpressJAK2021-02-16 View
510(k) K193306 PROViewLLZ2020-11-17 View
510(k) K193289 FastStroke, CT Perfusion 4DJAK2020-11-12 View

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