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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Nuclear medicine instruments
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Integrated CT/pet systems
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CT/pet systems
CT/pet systems
Z11020301
30 devices
Devices
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Vereos PET/CT System Upgrade
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
FDA 510(k)
K210880
Active
Cleared 19 May 2021
FDA 510(k)
K211764
Active
Cleared 6 Aug 2021
+2
authorizations
Positron Emission Tomography and Computed Tomography System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K231762
Active
Cleared 18 Jan 2024
CE/MDR
+1
authorizations
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDD
CE/MDR
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
NeuWise PET/CT
Shenyang Intelligent Neuclear Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Omni
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
Positron Emission Tomography and Computed Tomography System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K253564
Active
Cleared 13 Feb 2026
FDA 510(k)
K243538
Active
Cleared 12 Dec 2024
+6
authorizations
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Biograph mCT 20 Excel combination
Siemens Medical Solutions Usa, Inc.
·
,
US
Class IIb
CE/MDR
80512213
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CE/MDD
+1
authorizations
Positron Emission Tomography and Computed Tomography System
Open recall
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K232712
Active
Cleared 3 Oct 2023
FDA 510(k)
K223325
Active
Cleared 10 Mar 2023
+4
authorizations
Vereos PET/CT
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Omni Legend
GE Medical Systems, LLC
·
,
US
Class IIb
CE/MDR
GUDID
on market
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
GUDID
on market
Biograph mCT-S (20) -3R
Siemens Medical Solutions Usa, Inc.
·
,
US
Class IIb
FDA 510(k)
K060060
Active
Cleared 3 Feb 2006
CE/MDR
+1
authorizations
88000057
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CE/MDD
+1
authorizations
NeuEra
Shenyang Intelligent Neuclear Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
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