Medical device licence · 110615 · Class 3
GENIUS DIGITAL DIAGNOSTICS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 22, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110615
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 22, 2023
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENIUS ACCESSORY KIT
- GENIUS CERVICAL AI ALGORITHM
- GENIUS DIGITAL IMAGER
- GENIUS DIGITAL IMAGER COMPUTER
- GENIUS REVIEW STATION
- GENIUS REVIEW STATION COMPUTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.