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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Various instruments for radiodiagnostics and interventional procedures
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Various radiodiagnostic and interventional instruments - medical device software
Various radiodiagnostic and interventional instruments - medical device software
Z11039092
32 devices
Cina-Chest
Avicenna.ai
·
,
France
Class IIb
FDA 510(k)
K210237
Active
Cleared 19 May 2021
CE/MDR
Signal Mammo
Floy GmbH
·
,
Germany
Class I
CE/MDR
FFRangio System
Cathworks Ltd
·
,
Israel
Class IIb
CE/MDR
3903084CE01
Active
Valid to Oct 2028
FDA 510(k)
×2
K192442
Active
+1
authorizations
FEops HEARTguide
FEops NV
·
,
Belgium
Class IIa
FDA 510(k)
×2
K214066
Active
FDA De Novo
DEN200030
Active
Cleared 8 Sep 2021
+2
authorizations
Neowise
CEFLA s.c.
·
,
Italy
Class IIa
FDA 510(k)
K260716
Active
Cleared 4 May 2026
CE/MDR
+1
authorizations
Signal CT Vertebra
Floy GmbH
·
,
Germany
Class I
CE/MDR
Signal MR BMD
Floy GmbH
·
,
Germany
Class I
CE/MDR
Signal Knee
Floy GmbH
·
,
Germany
Class I
CE/MDR
Cina
Avicenna.ai
·
,
France
Class I
CE/MDD
GUDID
on market
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