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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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Mobile gamma cameras
Mobile gamma cameras
Z11020101
6 devices
Devices
SoloMobile
Ddd-Diagnostic A/S
·
,
DK
Class IIa
CE/MDD
GUDID
on market
Sentinella 102
General Equipment For Medical Imaging, S.A.
·
,
ES
Class IIa
FDA 510(k)
K110601
Active
Cleared 18 Mar 2011
CE/MDR
+1
authorizations
Sentinella 102 Horus
General Equipment For Medical Imaging, S.A.
·
,
ES
Class IIa
FDA 510(k)
K143156
Active
Cleared 18 Nov 2014
FDA 510(k)
K162052
Active
Cleared 18 Aug 2016
+2
authorizations
MyoSPECT
GE Medical Systems Israel, Functional Imaging
·
,
IL
Class IIa
CE/MDR
Sentinella Horus
General Equipment For Medical Imaging, S.A.
·
,
ES
Class IIa
CE/MDR
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