Medical device licence · 72904 · Class 3
O-ARM IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72904
- Licence holder
- Medtronic Navigation, Inc.Lafayette, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 8, 2006
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- O-ARM 1000 IMAGING SYSTEM - BASE OARM
- O-ARM 1000 IMAGING SYSTEM - CONTROL PENDANT
- O-ARM 1000 IMAGING SYSTEM - ENHANCED 3D IMAGING MODE
- O-ARM 1000 IMAGING SYSTEM - IMAGE STITCHING
- O-ARM 1000 IMAGING SYSTEM - MAIN UNIT
- O-ARM 1000 IMAGING SYSTEM - OPTION LASER ALIGNMENT
- O-ARM 1000 IMAGING SYSTEM - UPGRADE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.