Medical device licence · 85337 · Class 3
OPTIMA CT580
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
- 85337
- 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
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAIN UNIT
- OPTIMA CT580 - APPLICATIONS
- OPTIMA CT580 - ASIR TIO COLLECTOR
- OPTIMA CT580 - GANTRY
- OPTIMA CT580 - HARDWARE/SOFTWARE
- OPTIMA CT580 - OPERATOR CONSOLE
- OPTIMA CT580 - STANDARD TIO COLLECTOR
- OPTIMA CT580 - SYSTEM SOFTWARE
- OPTIMA CT580 - XTREAM INJECTOR SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.