Duns Number:551455046
Device Description: FusionSync is a software program that provides a registration engine to align (register) p 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.
Catalog Number
-
Brand Name
FUSIONSYNC
Version/Model Number
F1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
686c0878-af8e-4e2e-9282-4495a6554ff2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |