Medical device licence · 90322 · Class 2
IMAGE ANALYSIS SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed December 11, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90322
- Licence holder
- Ventana Medical Systems IncTucson, AZ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- December 11, 2012
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ESTROGEN RECEPTOR (SP1) IMAGE ANALYSIS SOFTWARE
- HER2 (4B5) IMAGE ANALYSIS SOFTWARE
- KI-67 (30-9) IMAGE ANALYSIS SOFTWARE
- P53 (DO-7) IMAGE ANALYSIS SOFTWARE
- PROGESTERONE RECEPTOR (1E2) IMAGE ANALYSIS SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.