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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 - 128 layers or more but less than 256 layers
Computed tomographs - 128 layers or more but less than 256 layers
Z11030606
30 devices
Devices
CT Areta RT/Rembra RT Upgrades
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
88000647
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Computed Tomographs
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
NeuViz Prime Max+
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
NeuViz Prime
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDD
GUDID
on market
Incisive CT
Open recall
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K180015
Active
Cleared 20 Mar 2018
FDA 510(k)
K212441
Active
Cleared 27 Apr 2022
+2
authorizations
CT Rembra RT
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K252992
Active
Cleared 23 Mar 2026
CE/MDR
NeuViz ACE 128
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CT Rembra
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
SCENARIA View
Fujifilm Corporation
·
,
JP
Class IIb
CE/MDR
GUDID
on market
Computed Tomographs
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Optima CT660
GE Healthcare Japan Corporation
·
,
JP
Class IIb
CE/MDD
NeuViz 128
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Revolution Altitude Elite
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Computed Tomography X-ray System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
FDA 510(k)
K241079
Active
Cleared 7 Jan 2025
+2
authorizations
Computed Tomography X-ray System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Ct 5300
Open recall
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K232491
Active
Cleared 3 May 2024
CE/MDR
+1
authorizations
Revolution Apex Select
Ge Hangwei Medical Systems Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
NAEOTOM Alpha
Siemens Healthcare GmbH
·
,
DE
Class IIb
CE/MDR
GUDID
on market
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