Medical Device Manufacturer · FR , Buc Cedex

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

38 submissions · 38 cleared · Since 2008

Recent clearances: CardIQ Suite, Senographe Pristina, Allia Moveo

38
Total
38
Cleared
0
Denied

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

38 devices
1-12 of 38
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
Radiology · 237d
Cleared Mar 24, 2026
Senographe Pristina
K260087 · MUE
Radiology · 71d
Cleared Dec 09, 2025
Allia Moveo
K251199 · OWB
Radiology · 235d
Cleared Jun 18, 2025
CardIQ Suite
K243672 · JAK
Radiology · 203d
Cleared Apr 21, 2025
VersaViewer
K243651 · LLZ
Radiology · 146d
Cleared Feb 25, 2025
3DXR
K243446 · OWB
Radiology · 111d
Cleared Aug 01, 2024
CardIQ Suite
K233731 · JAK
Radiology · 254d
Cleared Jan 25, 2024
BreView
K233714 · LLZ
Radiology · 66d
Cleared Oct 11, 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · OWB
Radiology · 68d
Cleared Jul 13, 2023
Spine Auto Views
K223424 · JAK
Radiology · 241d
Cleared Mar 21, 2023
FlightPlan for Embolization
K223490 · LLZ
Radiology · 120d
Cleared Nov 22, 2022
DynamicIQ
K222895 · KPS
Radiology · 60d

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