Medical Device Manufacturer · FR , Buc Cedex

GE Medical Systems SCS - FDA 510(k) Cleared Devices

37 submissions · 37 cleared · Since 2008

Recent clearances: Senographe Pristina, Allia Moveo, CardIQ Suite

Total

Cleared

Denied

GE Medical Systems SCS has 37 FDA 510(k) cleared radiology devices. Based in Buc Cedex, FR.

Latest FDA clearance: Mar 2026. Active since 2008.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Ge Medical Systems, LLC as regulatory consultant.

GE Medical Systems SCS is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - GE Medical Systems SCS

37 devices

1-12 of 37

Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR

FlightPlan for Embolization

Vision 2, EVARVision, TrackVision 2, HeartVision 2

K223152 · LLZ

Radiology · 47d

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GE Medical Systems SCS - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - GE Medical Systems SCS

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