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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 MRI/pet systems
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MRI/pet systems
MRI/pet systems
Z11020701
3 devices
Devices
Signa Pet/Mr
GE Medical Systems, LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
88000741
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K183014
Active
Cleared 27 Feb 2019
FDA 510(k)
K222540
Active
Cleared 14 Nov 2022
+4
authorizations
Signa Pet/Mr
Open recall
GE Medical Systems, LLC
·
,
US
Class IIa
FDA 510(k)
K213709
Active
Cleared 20 Jan 2022
FDA 510(k)
K163619
Active
Cleared 14 Feb 2017
+3
authorizations
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