Medical device licence · 85331 · Class 3
DISCOVERY CT590 RT
Yes: licensed in Canada
Licence status Issued (active); first licensed March 1, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85331
- Licence holder
- Ge Hangwei Medical Systems Co. Ltd.Beijing, China
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 1, 2011
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISCOVERY CT590 RT - ASIR TIO COLLECTOR
- DISCOVERY CT590 RT - GANTRY
- DISCOVERY CT590 RT - HARDWARE/SOFTWARE
- DISCOVERY CT590 RT - OPERATOR CONSOLE
- DISCOVERY CT590 RT - SYSTEM SOFTWARE
- DISCOVERY CT590 RT - XTREAM INJECTOR SOFTWARE
- MAIN UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.