Medical device licence · 65867 · Class 3
AXIEM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 21, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65867
- Licence holder
- Medtronic Navigation, Inc.Lafayette, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 21, 2004
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXIEM - CRANIAL SOFTWARE
- AXIEM - EM CRANIAL APPLICATION SET
- AXIEM - EM REGISTRATION WAND
- AXIEM - EM SPINE APPLICATION SOFTWARE
- AXIEM - EM-PCA PLUS SOFTWARE
- AXIEM - INSTRUMENT KIT
- AXIEM - NAV CART
- AXIEM - REFERENCE FRAME DRIVER
- AXIEM STYLET
- NON-INVASIVE PATIENT TRACKER
- SKULL-MOUNTED PATIENT TRACKER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.