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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) - software accessories
Computed tomographs (CT) - software accessories
Z11030682
42 devices
Devices
TruPlan
Circle Cardiovascular Imaging Inc
·
,
CA
Class IIa
FDA 510(k)
K202212
Active
Cleared 19 Feb 2021
CE/MDR
+1
authorizations
CustoMED Viewer
CustoMED Ltd
·
,
IL
Class I
CE/MDR
syngo.CT Neuro Perfusion
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
Brilliance iCT System Upgrade
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Head Auto Views
GE Medical Systems, LLC
·
,
US
Class IIa
CE/MDR
i-Dixel
J.morita Mfg.corp.
·
,
JP
Class I
CE/MDR
GUDID
on market
Virtual Nodule Clinic
Optellum Ltd
·
,
GB
Class IIb
FDA 510(k)
K202300
Active
Cleared 5 Mar 2021
CE/MDR
syngo.CT Cardiac Function
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
Veolity
Mevis Medical Solutions AG
·
,
DE
Class IIa
FDA 510(k)
K201501
Active
Cleared 23 Feb 2021
CE/MDR
+1
authorizations
syngo.CT LVO Detection
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
MeVis Liver Suite
Mevis Medical Solutions AG
·
,
DE
Class IIa
CE/MDR
GUDID
on market
syngo.CT CaScoring
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
syngo.CT ASPECTS
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
InferOperate® Software
Infervision Medical Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
syngo.CT Vessel Hyperdensities
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
syngo.CT Body Perfusion
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
Hermes
Optellum Ltd
·
,
GB
Class I
CE/MDR
MeVis Liver Suite
Mevis Medical Solutions AG
·
,
DE
Class IIa
FDA 510(k)
K232045
Active
Cleared 27 Oct 2023
CE/MDR
+1
authorizations
syngo.CT Brain Quantification
Siemens Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
StrokeSENS
Circle Cardiovascular Imaging
·
,
CA
Class IIa
CE/MDR
GUDID
on market
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