Medical device licence · 104723 · Class 3
REVOLUTION APEX
Yes: licensed in Canada
Licence status Issued (active); first licensed June 4, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104723
- Licence holder
- Ge Medical Systems, LlcWaukesha, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 4, 2020
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REVOLUTION APEX
- REVOLUTION APEX ELITE
- REVOLUTION APEX PLUS
- REVOLUTION CT ES WITH APEX EDITION
- REVOLUTION CT WITH APEX EDITION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.