Medical Device Manufacturer · FR , Buc Cedex

GE Medical Systems SCS

36 submissions · 36 cleared · Since 2008
36
Total
36
Cleared
0
Denied

GE Medical Systems SCS — FDA 510(k) Submissions

GE Medical Systems SCS has submitted 36 FDA 510(k) premarket notifications since 2008, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Tomography, Computed, System, Image Processing, Radiological, Interventional Fluoroscopic X-ray System, System, Tomography, Computed, Emission, Full Field Digital, System, X-ray, Mammographic . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
Allia Moveo
K251199 · OWB Interventional... · Radiology
Dec 2025 235d
CardIQ Suite
K243672 · JAK System, X-ray,... · Radiology
Jun 2025 203d
VersaViewer
K243651 · LLZ System, Image Processing,... · Radiology
Apr 2025 146d
3DXR
K243446 · OWB Interventional... · Radiology
Feb 2025 111d
CardIQ Suite
K233731 · JAK System, X-ray,... · Radiology
Aug 2024 254d
BreView
K233714 · LLZ System, Image Processing,... · Radiology
Jan 2024 66d
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · OWB Interventional... · Radiology
Oct 2023 68d
Spine Auto Views
K223424 · JAK System, X-ray,... · Radiology
Jul 2023 241d
FlightPlan for Embolization
K223490 · LLZ System, Image Processing,... · Radiology
Mar 2023 120d
DynamicIQ
K222895 · KPS System, Tomography,... · Radiology
Nov 2022 60d
Vision 2, EVARVision, TrackVision 2, HeartVision 2
K223152 · LLZ System, Image Processing,... · Radiology
Nov 2022 47d
Liver Suite
K211180 · JAK System, X-ray,... · Radiology
May 2022 377d
CardIQ Suite
K213725 · JAK System, X-ray,... · Radiology
Mar 2022 105d
FlightPlan for Liver
K210807 · LLZ System, Image Processing,... · Radiology
Oct 2021 219d
PET VCAR
K211247 · KPS System, Tomography,... · Radiology
Jul 2021 92d
VesselIQ Xpress
K200626 · JAK System, X-ray,... · Radiology
Feb 2021 343d
PROView
K193306 · LLZ System, Image Processing,... · Radiology
Nov 2020 354d
FastStroke, CT Perfusion 4D
K193289 · JAK System, X-ray,... · Radiology
Nov 2020 351d
Hepatic VCAR
K193281 · JAK System, X-ray,... · Radiology
Mar 2020 114d
CardIQ Flow
K192277 · KPS System, Tomography,... · Radiology
Feb 2020 176d
FlightPlan for Embolization
K193261 · LLZ System, Image Processing,... · Radiology
Jan 2020 59d
Bone VCAR (BVCAR)
K183204 · JAK System, X-ray,... · Radiology
Apr 2019 140d
Thoracic VCAR with GSI Pulmonary Perfusion
K183210 · LLZ System, Image Processing,... · Radiology
Mar 2019 130d
GSI Viewer with GSI Fat Option
K180225 · JAK System, X-ray,... · Radiology
Apr 2018 88d
Stereo 3D option for Vision Applications
K152352 · LLZ System, Image Processing,... · Radiology
Jan 2016 153d
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