GE Medical Systems SCS
GE Medical Systems SCS holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 13 FDA device recalls on record.
Top product codes for GE Medical Systems SCS
FDA recalls by GE Medical Systems SCS
10 most recent of 13- Z-2553-2026 — GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- Z-0068-2026 — AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
- Z-1779-2024 — GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
- Z-1780-2024 — GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
- Z-1781-2024 — GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
- Z-1778-2024 — GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
- Z-1777-2024 — GE Healthcare Innova IGS 5, computed tomography x-ray system
- Z-1783-2024 — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Z-1782-2024 — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
- Z-0862-2024 — Senographe Pristina
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by GE Medical Systems SCS
- K253770 — CardIQ Suite
- K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- K251199 — Allia Moveo
- K243672 — CardIQ Suite
- K243651 — VersaViewer
- K243446 — 3DXR
- K233731 — CardIQ Suite
- K233714 — BreView
- K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- K223424 — Spine Auto Views
- K223490 — FlightPlan for Embolization
- K222895 — DynamicIQ
- K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2
- K211180 — Liver Suite
- K213725 — CardIQ Suite
- K210807 — FlightPlan for Liver
- K211247 — PET VCAR
- K200626 — VesselIQ Xpress
- K193306 — PROView
- K193289 — FastStroke, CT Perfusion 4D
- K193281 — Hepatic VCAR
- K192277 — CardIQ Flow
- K193261 — FlightPlan for Embolization
- K183204 — Bone VCAR (BVCAR)
- K183210 — Thoracic VCAR with GSI Pulmonary Perfusion
- K180225 — GSI Viewer with GSI Fat Option
- K152352 — Stereo 3D option for Vision Applications
- K152584 — Stroke VCAR
- K133278 — DISCOVERY IGS 740
- K133649 — HEPATIC VCAR
- K131885 — SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
- K121827 — GSI VIEWER WITH VUE OPTION
- K122164 — MR VESSELLQ XPRESS
- K120910 — CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
- K113403 — GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
- K092639 — INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
- K093234 — INTEGRATED REGISTRATION
- K073153 — CARDIQ FUNCTION XPRESS
Data sourced from openFDA. This site is unofficial and independent of the FDA.