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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 - 64 layers or more but less than 128 layers
Computed tomographs - 64 layers or more but less than 128 layers
Z11030605
26 devices
Devices
NeuViz 64 In
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDD
GUDID
on market
Computed Tomography X-ray System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDD
FDA 510(k)
K241166
Active
Cleared 14 Jan 2025
+2
authorizations
IQon Spectral CT
Open recall
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
FDA 510(k)
K193454
Active
Cleared 24 Jan 2020
CE/MDR
+1
authorizations
CT Areta RT
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Frontier ES
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Revolution Ascend
GE Healthcare Japan Corporation
·
,
JP
Class IIb
CE/MDR
GUDID
on market
NeuViz ACE UP
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Ascend Plus
Open recall
GE Healthcare Japan Corporation
·
,
JP
Class IIb
FDA 510(k)
K203169
Active
Cleared 20 Nov 2020
FDA 510(k)
K213938
Active
Cleared 4 Feb 2022
+2
authorizations
X-ray computed Tomography System
Shenzhen Anke High-Tech Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Revolution Ascend Select
GE Healthcare Japan Corporation
·
,
JP
Class IIb
CE/MDR
GUDID
on market
SOMATOM Pro.Pulse
Siemens Shanghai, Medical Equipment Ltd.
·
,
CN
Class IIb
CE/MDR
NeuViz ACE 64e
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Computed Tomographs
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Ascend Elite
GE Healthcare Japan Corporation
·
,
JP
Class IIb
CE/MDR
GUDID
on market
Revolution Frontier
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Computed Tomographs
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
NeuViz ACE 64i
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Revolution Frontier Gen 3_HD Refresh Package
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
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