Medical device licence · 108604 · Class 2
VANTAGE FORTIAN
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108604
- Licence holder
- Canon Inc.Tokyo, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 2, 2022
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 10GBE HIGH SPEED RECONSTRUCTION KIT
- 4D FLOW APPLICATION
- ADDITIONAL PATIENT CAMERA PACKAGE
- APPS FOR TABLET
- CEILING CAMERA PACKAGE
- DICOM
- FOOT SWITCH UNIT
- HIGHER ORDER SHIM KIT
- MANDATORY SOFTWARE AND EQUIPMENT
- MR ELASTOGRAPHY
- OPTIONAL RF COILS
- OPTIONAL SOFTWARE
- OPTIONAL SOFTWARE PACKAGE
- SECOND CONSOLE
- SOFTWARE UPGRADE PACKAGE (10.0)
- SOFTWARE UPGRADE PACKAGE (9.0)
- SOFTWARE VERSION
- VANTAGE FORTIAN - MAIN UNIT
- WIRELESS CARDIAC GATING SYSTEM
- WIRELESS PERIPHERAL PULSE AND RESPIRATORY GATING SYSTEM
- ZOOM DWI APPLICATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.