Medical device licence · 71643 · Class 3
DISCOVERY STE8 PET/CT SCANNER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71643
- Licence holder
- Ge Medical Systems, LlcWaukesha, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 16, 2006
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISCOVERY STE8 PET/CT SCANNER SYSTEM - MAIN UNIT
- DISCOVERY STE8 PET/CT SCANNER SYSTEM - PIN SOURCE
- DISCOVERY STE8 PET/CT SCANNER SYSTEM - SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.