Medical device licence · 85540 · Class 2
COILS FOR MR SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 21, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85540
- Licence holder
- Ge Medical Systems, LlcWaukesha, WI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 21, 2011
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIAC ARRAY
- FLEX COIL
- HEAD COIL
- PET/MR CENTRAL MOLECULAR ARRAY (CMA)
- PHASED ARRAY FLEX COIL
- ROUND COIL
- TORSO ARRAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.