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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
Devices
Coronary CT Image Intelligent 3D-reconstruction Software
SenseCare Smart Health Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Head Auto Views
Ge Medical Systems, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
CardIQ Xpress 2.0
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
ClariCT.AI
ClariPI Inc.
·
,
KR
Class IIa
FDA 510(k)
K212074
Active
Cleared 27 Jul 2021
FDA 510(k)
K183460
Active
Cleared 13 Jun 2019
+1
authorizations
CardIQ Xpress 2.0
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Liver CT Image Processing Software
SenseCare Smart Health Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Pulmonary nodules CT imaging aided detection software
Hangzhou Deepwise & League of PHD Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Careverse CTPDoc
Yukun (Beijing) Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Liver Suite
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K211180
Active
Cleared 2 May 2022
CE/MDR
AdvantageCTC Pro3D EC
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Rayscan
Azmed Sas
·
,
FR
Class IIa
CE/MDR
Picture Archiving and Communications System
SenseCare Smart Health Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
Careverse EasyAspect
Yukun (Beijing) Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
SnapShot Freeze
GE Medical Systems, LLC
·
,
US
Class IIa
CE/MDR
Hepatic VCAR
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K193281
Active
Cleared 20 Mar 2020
FDA 510(k)
K133649
Active
Cleared 22 Apr 2014
+1
authorizations
88000843
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K173001
Active
Cleared 7 Nov 2018
FDA 510(k)
K183170
Active
Cleared 24 Jun 2019
+1
authorizations
MaxFOV 2
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
CT Perfusion 4D
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
CT Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
CN
Class IIa
CE/MDR
AdvantageCTC Pro3D EC
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
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