Medical device licence · 107454 · Class 3
GENIUS AI DETECTION
Yes: licensed in Canada
Licence status Issued with conditions; first licensed March 3, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107454
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- March 3, 2022
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENIUS AI DETECTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.