Identity
- Trade Name
- FUSIONSYNC FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- FusionSync is a software program that provides a registration engine to align (register) pairs of images from same and different imaging modalities. The platform-independent registration engine is designed as a plug-in component that has the ability to extend the productivity of existing viewers like CAD workstations or PACS. The graphical user interface of FusionSync is designed as a plug-in component for aycan workstation OsiriX PRO. It includes functionality to display the original volumetric data and the results of the registration operation. The graphical user interface allows to control the registration engine and fusion visualization. FDA UDI
- Model / Reference
- F1 FDA UDI
- Description
- FusionSync is a software program that provides a registration engine to align (register) pairs of images from same and different imaging modalities. The platform-independent registration engine is designed as a plug-in component that has the ability to extend the productivity of existing viewers like CAD workstations or PACS. The graphical user interface of FusionSync is designed as a plug-in component for aycan workstation OsiriX PRO. It includes functionality to display the original volumetric data and the results of the registration operation. The graphical user interface allows to control the registration engine and fusion visualization. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ECMAFUSIONSYNCF10 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system workstation
Fusionsync by Chimaera GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Chimaera GmbH
Sources (1)
- FDA UDI 686c0878-af8e-4e2e-9282-4495a6554ff2 34 fields · synced May 30, 2026