Chimaera GmbH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

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FUSIONSYNC - ECMAFUSIONSYNCF10 Catalog Number :

Device Description : FusionSync is a software program that provides a registration engine to align (r FusionSync is a software program that provides a registration engine to align (register) pairs ofimages from same and different imaging modalities. The platform-independent registration engine isdesigned as a plug-in component that has the ability to extend the productivity of existing viewerslike CAD workstations or PACS. The graphical user interface of FusionSync is designed as a plug-incomponent for aycan workstation OsiriX PRO. It includes functionality to display the originalvolumetric data and the results of the registration operation. The graphical user interface allows tocontrol the registration engine and fusion visualization.

Device Class : 2

Duns Number: 551455046

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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