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GE Medical Systems SCS

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories5
Latest Approval2026-03-24
TypeNumberDevice NameCodeDate
510(k) K260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright MUE 2026-03-24 View
510(k) K251199 Allia Moveo OWB 2025-12-09 View
510(k) K243672 CardIQ Suite JAK 2025-06-18 View
510(k) K243651 VersaViewer LLZ 2025-04-21 View
510(k) K243446 3DXR OWB 2025-02-25 View
510(k) K233731 CardIQ Suite JAK 2024-08-01 View
510(k) K233714 BreView LLZ 2024-01-25 View
510(k) K232344 Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR OWB 2023-10-11 View
510(k) K223424 Spine Auto Views JAK 2023-07-13 View
510(k) K223490 FlightPlan for Embolization LLZ 2023-03-21 View
510(k) K222895 DynamicIQ KPS 2022-11-22 View
510(k) K223152 Vision 2, EVARVision, TrackVision 2, HeartVision 2 LLZ 2022-11-22 View
510(k) K211180 Liver Suite JAK 2022-05-02 View
510(k) K213725 CardIQ Suite JAK 2022-03-11 View
510(k) K210807 FlightPlan for Liver LLZ 2021-10-22 View
510(k) K211247 PET VCAR KPS 2021-07-27 View
510(k) K200626 VesselIQ Xpress JAK 2021-02-16 View
510(k) K193306 PROView LLZ 2020-11-17 View
510(k) K193289 FastStroke, CT Perfusion 4D JAK 2020-11-12 View
510(k) K193281 Hepatic VCAR JAK 2020-03-20 View
510(k) K192277 CardIQ Flow KPS 2020-02-14 View
510(k) K193261 FlightPlan for Embolization LLZ 2020-01-24 View
510(k) K183204 Bone VCAR (BVCAR) JAK 2019-04-08 View
510(k) K183210 Thoracic VCAR with GSI Pulmonary Perfusion LLZ 2019-03-29 View
510(k) K180225 GSI Viewer with GSI Fat Option JAK 2018-04-24 View
510(k) K152352 Stereo 3D option for Vision Applications LLZ 2016-01-20 View
510(k) K152584 Stroke VCAR JAK 2016-01-20 View
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