Medical device licence · 97224 · Class 3
O-ARM O2 IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97224
- Licence holder
- Medtronic Navigation, Inc.Lafayette, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 30, 2016
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KIT SVC O2 COMPUTER IAS
- KIT SVC O2 COMPUTER MVS SVR
- O-ARM O2 ADVANCED VIEWING
- O-ARM O2 COLLIMATED AXIAL 3D
- O-ARM O2 ENHAN CRAN 3D EC3D
- O-ARM O2 HI DEF 3D HD3D
- O-ARM O2 IMAGE ACQUISITION SYSTEM
- O-ARM O2 IMAGING SYSTEM
- O-ARM O2 ISO-WAG ROTATION
- O-ARM O2 MOBILE VIEW STATION
- O-ARM O2 MULTI FIELD OF VIEW
- O-ARM O2 REMOTE PENDANT
- O-ARM O2 STEREOTAXY
- O-ARM O2 SYS NAV INTERFACE
- O-ARM O2 TRACKER KIT
- O-ARM OPTIONAL REMOTE PENDANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.