Medical device licence · 95773 · Class 2
BRAINLAB ELEMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95773
- Licence holder
- Brainlab SeMunich, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 16, 2015
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRAINLAB ELEMENTS BOLD MRI MAPPING
- BRAINLAB ELEMENTS CONTOURING
- BRAINLAB ELEMENTS FIBERTRACKING
- BRAINLAB ELEMENTS IMAGE FUSION
- BRAINLAB ELEMENTS IMAGE FUSION ANGIO
- BRAINLAB ELEMENTS OBJECT MANAGEMENT
- BRAINLAB ELEMENTS SMARTBRUSH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.