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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 - 256 layers or more
Computed tomographs - 256 layers or more
Z11030607
21 devices
Devices
Revolution Apex Elite
GE Medical Systems, LLC
·
,
US
Class IIb
CE/MDR
GUDID
on market
Revolution CT
Open recall
GE Medical Systems, LLC
·
,
US
Class IIb
FDA 510(k)
K163213
Active
Cleared 16 Dec 2016
FDA 510(k)
K133705
Active
Cleared 11 Apr 2014
+2
authorizations
Brilliance iCT
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Revolution CT ES
GE Medical Systems, LLC
·
,
US
Class IIb
CE/MDR
GUDID
on market
NeuViz Glory
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Apex Expert
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution CT ES with Apex edition
Open recall
GE Medical Systems, LLC
·
,
US
Class IIb
FDA 510(k)
K213715
Active
Cleared 17 Dec 2021
FDA 510(k)
K191777
Active
Cleared 26 Jul 2019
+2
authorizations
Revolution Apex
Ge Medical Systems, Inc.
·
,
US
Class IIb
CE/MDR
GUDID
on market
T2
Open recall
Osstem Implant Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K212303
Active
Cleared 21 Sep 2021
CE/MDD
+1
authorizations
NeuViz Epoch
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Computed Tomography X-ray System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Computed Tomography X-ray System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K172135
Active
Cleared 2 Mar 2018
CE/MDR
Revolution Apex Plus
GE Medical Systems, LLC
·
,
US
Class IIb
CE/MDR
GUDID
on market
Revolution CT with Apex edition
GE Medical Systems, LLC
·
,
US
Class IIb
CE/MDR
GUDID
on market
NeuViz Epoch+
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Apex Select with Plus Edition
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Revolution Vibe
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
NeuViz Glory+
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Apex Select with Elite Edition
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
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