Medical device licence · 94299 · Class 2
COILS FOR MR SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 27, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94299
- Licence holder
- Ge Healthcare (Tianjin) Company LimitedTianjin, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 27, 2014
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.5T 4CH LARGE FLEX COIL
- 1.5T 4CH SMALL FLEX COIL
- 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY
- 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY
- EXPRESS COIL - ANTERIOR ARRAY
- EXPRESS COIL - HEAD NECK ARRAY
- GE 8CH FOOT ANKLE COIL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.