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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
ClariSIGMAM
ClariPI Inc.
·
,
South Korea
Class I
FDA 510(k)
K203785
Active
Cleared 10 Sep 2021
CE/MDD
Colon VCAR EC
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
CardEP
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
TAVI Analysis
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Liver Suite
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
CT Perfusion 4D
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Rayscape
Mindfully Technologies SRL
·
,
Romania
Class I
CE/MDD
InferOperate®
Infervision Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Careverse BMDDoc
Yukun (Beijing) Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Thoracic VCAR
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
TAVI Analysis
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
GSI Viewer
GE Medical Systems SCS
·
,
France
Class IIa
FDA 510(k)
K121827
Active
Cleared 13 Sep 2012
CE/MDR
Careverse StrokeDoc
Yukun (Beijing) Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
SmartMAR
GE Healthcare Japan Corporation
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
Bone VCAR
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
·
,
Japan
Class IIa
FDA 510(k)
×4
K193170
Active
Cleared 13 Dec 2019
CE/MDR
+1
authorizations
CardIQ Function Xpress
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Hepatic VCAR
GE Medical Systems SCS
·
,
France
Class IIa
CE/MDR
Stroke VCAR
GE Medical Systems SCS
·
,
France
Class IIa
FDA 510(k)
K152584
Active
Cleared 20 Jan 2016
CE/MDR
Careverse LiverMRDoc
Yukun (Beijing) Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
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