Medical device licence · 108535 · Class 2
GE MR COILS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108535
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 10, 2022
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.5T 16CH SHOULDER COIL
- 1.5T 32CH CARDIAC COIL - ANTERIOR
- 1.5T 8CH FOOT ANKLE COIL
- 1.5T HD 8CH WRIST ARRAY (FLAT BASE)
- 1.5T HD 8CH WRIST ARRAY (RECEIVE ONLY)
- 1.5T HD T/R KNEE ARRAY
- 1.5T HD T/R KNEE COIL (FLAT BASE)
- 1.5T HD T/R QUAD EXTREMITY COIL
- 1.5T HD T/R QUAD EXTREMITY COIL (FLAT BASE)
- 3.0T 16CH SHOULDER COIL
- 3.0T 32CH CARDIAC COIL - ANTERIOR
- 3.0T HD 8CH WRIST ARRAY
- 3.0T HD T/R KNEE ARRAY
- 3.0T HD T/R KNEE COIL (FLAT BASE)
- 3.0T HD T/R QUAD EXTREMITY COIL
- 3.0T HD T/R QUAD EXTREMITY COIL (FLAT BASE)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.