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Integrated CT/pet systems - medical device software
Integrated CT/pet systems - medical device software
Z11020392
7 devices
Devices
PLANET Onco Dose
Dosisoft
·
,
FR
Class IIb
CE/MDD
PET/CT Computer-Aided Diagnostic Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
CN
Class IIa
CE/MDR
88000845
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K172998
Active
Cleared 5 Apr 2018
FDA 510(k)
K192630
Active
Cleared 11 Jun 2020
+1
authorizations
88001298
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K230039
Active
Cleared 20 Jul 2023
FDA 510(k)
K233176
Active
Cleared 20 Dec 2023
+2
authorizations
PET/CT Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
CN
Class IIa
CE/MDR
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