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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/gamma camera systems
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CT/gamma camera systems
CT/gamma camera systems
Z11020201
29 devices
Devices
StarGuide MDD to MDR Upgrade
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
GUDID
on market
StarGuide to StarGuide with dsCZT Detectors
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
Nm/Ct 850
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
GUDID
on market
StarGuide
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
GUDID
on market
Nm/Ct 870 Dr
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
GUDID
on market
StarGuide GX
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
Nm/Ct 870 Dr
GE Hualun Medical Systems Co., Ltd
·
,
CN
Class IIb
CE/MDD
Veriton Ct 464
Spectrum Dynamics Medical ltd
·
,
IL
Class IIb
CE/MDR
3902904CE01
Active
Valid to Aug 2027
GUDID
on market
Veriton CT64
Spectrum Dynamics Medical SA
·
,
CH
Class IIb
CE/MDR
3902983CE01
Active
Valid to Nov 2027
Campo
Liaoning Campo Imaging Medical Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CE/MDD
StarGuide
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDD
GUDID
on market
Nm/Ct 860
GE Hualun Medical Systems Co., Ltd
·
,
CN
Class IIb
CE/MDD
Veriton Ct 264
Spectrum Dynamics Medical ltd
·
,
IL
Class IIb
CE/MDR
3902904CE01
Active
Valid to Aug 2027
GUDID
on market
Aurora
GE Hualun Medical Systems Co., Ltd
·
,
CN
Class IIb
CE/MDR
Aurora
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
FDA 510(k)
K243605
Active
Cleared 17 Jan 2025
FDA 510(k)
K251153
Active
Cleared 12 Jun 2025
+2
authorizations
Campo
Liaoning Campo Imaging Medical Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CE/MDD
Nm/Ct 870 Dr
GE Hualun Medical Systems Co., Ltd
·
,
CN
Class IIb
CE/MDR
Veriton Ct 216
Spectrum Dynamics Medical ltd
·
,
IL
Class IIb
CE/MDR
3902904CE01
Active
Valid to Aug 2027
GUDID
on market
Nm/Ct 860
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIb
CE/MDR
GUDID
on market
Veriton Ct 364
Spectrum Dynamics Medical ltd
·
,
IL
Class IIb
CE/MDR
3902904CE01
Active
Valid to Aug 2027
CE/MDR
3902983CE01
Active
Valid to Nov 2027
+1
authorizations
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