Medical device licence · 79007 · Class 3
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79007
- Licence holder
- Elekta Solutions AbStockholm, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 6, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM - CONTROLLER
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM - COOLING TUBING ASSEMBLY
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM - HDR X-RAY SOURCE
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM - PHYSICS ACCESSORIES KIT
- AXXENT RECTAL SURFACE APPLICATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.