Medical device licence · 66027 · Class 2
COILS FOR MR SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66027
- Licence holder
- Ge Healthcare CoilsAurora, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 4, 2004
- Devices covered
- 37
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.5T AIR MP
- 3.0 T HD HEAD, NECK, AND SPINE ARRAY
- 3.0T AA
- 3.0T AIR MP L
- 3.0T AIR MP M
- 48CH HEAD COIL
- AIR ANTERIOR ARRAY
- AIR POSTERIOR ARRAY
- ANTERIOR ARRAY (AA)
- BODY ARRAY
- CARDIAC ARRAY
- CTL ARRAY COIL
- GEM ANTERIOR ARRAY
- GEM BREAST ARRAY
- GEM HEAD NECK UNIT
- GEM OPEN ARRAY
- GEM PERIPHERAL/VASCULAR ARRAY
- GEM POSTERIOR ARRAY
- HD BODY ARRAY
- HD BREAST ARRAY
- HD CARDIAC ARRAY
- HD CTL ARRAY
- HD HEAD, NECK, AND SPINE ARRAY
- HD LOWER LEG ARRAY
- HD NEUROVASCULAR ARRAY
- HD SHOULDER ARRAY
- HD TORSO ARRAY
- HEAD NECK UNIT (HNU)
- INTERVENTIONAL BODY COIL
- PHASED ARRAY CTAL SPINE COIL
- PHASED ARRAY KNEE AND FOOT COIL
- PHASED ARRAY SHOULDER ARRAY
- PHASED ARRAY TORSO COIL
- SHOULDER ARRAY
- TDI HEAD NECK ARRAY
- TDI POSTERIOR ARRAY
- TORSO ARRAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.