Medical device licence · 86931 · Class 4
PANTHER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 16, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86931
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- August 16, 2011
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PANTHER FUSION MODULE
- PANTHER FUSION SYSTEM
- PANTHER SYSTEM
- PANTHER SYSTEM LABORATORY DEVELOPED TEST REAL-TIME TMA SOFTWARE
- PANTHER SYSTEM LABORATORY DEVELOPED TEST SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.