Medical device licence · 72132 · Class 3
BRIGHTSPEED EXCEL CT SCANNER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 11, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72132
- Licence holder
- Ge Hangwei Medical Systems Co. Ltd.Beijing, China
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 11, 2006
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRIGHTSPEED EXCEL CT SCANNER SYSTEM - MAIN UNIT
- BRIGHTSPEED EXCEL CT SCANNER SYSTEM - SOFTWARE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “brightspeed”. A notice may cover another product or only some lots: read it to see what it covers.
- Brightspeed Scanner Systems (2017-06-01)June 13, 2017 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.