GE Medical Systems SCS is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
GE Medical Systems SCS - FDA 510(k) Cleared Devices
Recent clearances: CardIQ Suite, Senographe Pristina, Allia Moveo
38
Total
38
Cleared
0
Denied
GE Medical Systems SCS has 38 FDA 510(k) cleared radiology devices. Based in Buc Cedex, FR.
Latest FDA clearance: Jul 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.
Regulatory submissions have been managed by Intertek Testing Services, Ge Medical Systems, LLC and GE Healthcare.
FDA 510(k) Regulatory Record - GE Medical Systems SCS
38 devices
Cleared
Jul 21, 2026
CardIQ Suite
Radiology
237d
Cleared
Mar 24, 2026
Senographe Pristina
Radiology
71d
Cleared
Dec 09, 2025
Allia Moveo
Radiology
235d
Cleared
Jun 18, 2025
CardIQ Suite
Radiology
203d
Cleared
Apr 21, 2025
VersaViewer
Radiology
146d
Cleared
Feb 25, 2025
3DXR
Radiology
111d
Cleared
Aug 01, 2024
CardIQ Suite
Radiology
254d
Cleared
Jan 25, 2024
BreView
Radiology
66d
Cleared
Oct 11, 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
Radiology
68d
Cleared
Jul 13, 2023
Spine Auto Views
Radiology
241d
Cleared
Mar 21, 2023
FlightPlan for Embolization
Radiology
120d
Cleared
Nov 22, 2022
DynamicIQ
Radiology
60d
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