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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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Computerised gamma cameras
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Fixed station gamma cameras with multiple heads - with ‘total body’ acquisition
Fixed station gamma cameras with multiple heads - with ‘total body’ acquisition
Z11020105
9 devices
Devices
Nm 830
GE Hualun Medical Systems Co., Ltd
·
,
CN
Class IIa
CE/MDD
Nm 830
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIa
CE/MDR
GUDID
on market
Veriton Nm 400
Spectrum Dynamics Medical ltd
·
,
IL
Class IIa
CE/MDR
GUDID
on market
Veriton Nm 300
Spectrum Dynamics Medical ltd
·
,
IL
Class IIa
FDA 510(k)
K180514
Active
Cleared 25 Apr 2018
CE/MDR
+1
authorizations
MultiCam pro
Inter Medical Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDR
QuantumCam
Ddd-Diagnostic A/S
·
,
DK
Class IIa
FDA 510(k)
K161674
Active
Cleared 20 Oct 2016
CE/MDD
+1
authorizations
Veriton Nm 200
Spectrum Dynamics Medical ltd
·
,
IL
Class IIa
CE/MDR
GUDID
on market
MultiCam pro
Inter Medical Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDR
AnyScan DUO-Thera SPECT/CT
Mediso Medical Imaging Systems Ltd.
·
,
HU
Class IIb
CE/MDR
AnyScan TRIO-IQMAX SPECT/CT
Mediso Medical Imaging Systems Ltd.
·
,
HU
Class IIb
CE/MDR
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