Medical device licence · 105857 · Class 3
HIRISE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 23, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105857
- Licence holder
- Curvebeam, Llc.Hatfield, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 23, 2021
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CURVEBEAM X-RAY POWER SUPPLY
- CURVEBEAM X-RAY TUBEHEAD ASSEMBLY
- HIRISE CONE BEAM CT X-RAY IMAGING SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.