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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Integrated CT/pet systems
Integrated CT/pet systems
Z110203
37 devices
Subcategories
5
Z11020301
CT/pet systems
30
devices
Z11020380
Integrated CT/pet systems - hardware accessories
0
devices
Z11020382
Integrated CT/pet systems - software accessories
0
devices
Z11020385
Integrated CT/pet systems - consumables
0
devices
Z11020392
Integrated CT/pet systems - medical device software
7
devices
Devices
Discovery IQ
Open recall
GE Medical Systems, LLC
·
,
United States
Class IIb
FDA 510(k)
K141477
Active
Cleared 18 Sep 2014
CE/MDR
+1
authorizations
NeuWin
Shenyang Intelligent Neuclear Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
PET/CT Computer-Aided Diagnostic Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
China
Class IIa
CE/MDR
88000845
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×2
K172998
Active
Cleared 5 Apr 2018
CE/MDD
Medical Image Post-processing Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×2
K230039
Active
Cleared 20 Jul 2023
CE/MDR
+1
authorizations
PET/CT Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
China
Class IIa
CE/MDR
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