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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Computed tomographs (CT)
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Computed tomographs (CT) - medical device software
Computed tomographs (CT) - medical device software
Z11030692
129 devices
Spectral Color Overlay
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
AdvantageCTC Pro3D EC
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
FastStroke
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
CT Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K240411
Active
Cleared 6 Sep 2024
CE/MDR
Liver Suite
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
CT Computer-Aided Triage Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K242292
Active
Cleared 24 Sep 2024
CE/MDR
Rayscan
Azmed Sas
·
,
France
Class IIa
CE/MDR
CT Perfusion 4D Neuro
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Careverse FFR
Yukun (Beijing) Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Head Auto Views
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Colon VCAR EC
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Revolution UPG 3
GE Medical Systems, LLC
·
,
United States
Class IIb
CE/MDR
GUDID
on market
CardIQ Suite
GE Medical Systems SCS
·
,
France
Class IIa
FDA 510(k)
×3
K243672
Active
Cleared 18 Jun 2025
CE/MDR
ASiR-V
GE Healthcare Japan Corporation
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
CT Perfusion Image Processing Software
SenseCare Smart Health Technology Co., Ltd.
·
,
China
Class I
CE/MDR
Lung VCAR
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Medical Image Post-processing Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K233209
Active
Cleared 17 May 2024
CE/MDR
+1
authorizations
ClariPulmo
ClariPI Inc.
·
,
South Korea
Class IIa
FDA 510(k)
K203783
Active
Cleared 6 Apr 2022
CE/MDD
Careverse CoronaryDoc
Yukun (Beijing) Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Liver Suite
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
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