Medical device licence · 97166 · Class 2
POWERLOOK TOMO DETECTION SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97166
- Licence holder
- Icad, Inc.Beavercreek, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- June 23, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- POWERLOOK TOMO DETECTION SOFTWARE
- PROFOUND AI
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.