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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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Mammography systems
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Mammography systems - software accessories
Mammography systems - software accessories
Z11030282
8 devices
Devices
densitas® densityAI™
Densitas Inc
·
,
CA
Class I
CE/MDR
GUDID
on market
MammoScreen
Therapixel SA
·
,
FR
Class IIa
FDA 510(k)
K192854
Active
Cleared 25 Mar 2020
CE/MDD
intelliMammo™ densityAI™
Densitas Inc
·
,
CA
Class I
CE/MDR
GUDID
on market
Vara Flux
MX Healthcare GmbH
·
,
DE
Class I
CE/MDR
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