Medical device licence · 31731 · Class 2
INTERA 1.5T MRI SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 10, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 31731
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 10, 2001
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INERA 1.5T MRI SYSTEM - HAND WRIST COIL
- INTERA 1.5T MRI SYSTEM - 1H SPECTRO T/R HEAD COIL
- INTERA 1.5T MRI SYSTEM - ADD QUADRATURE COIL
- INTERA 1.5T MRI SYSTEM - C1 COIL
- INTERA 1.5T MRI SYSTEM - CIRCULAR COIL
- INTERA 1.5T MRI SYSTEM - E1 COIL
- INTERA 1.5T MRI SYSTEM - ENDO COIL
- INTERA 1.5T MRI SYSTEM - KNEE/FOOT COIL
- INTERA 1.5T MRI SYSTEM - MAIN UNIT
- INTERA 1.5T MRI SYSTEM - MICROSCOPIC COIL
- INTERA 1.5T MRI SYSTEM - MICROSCOPY COIL SET
- INTERA 1.5T MRI SYSTEM - PAIRED TMJ COIL
- INTERA 1.5T MRI SYSTEM - QUADRATURE VOLUME NECK COIL
- INTERA 1.5T MRI SYSTEM - SENSE BODY COIL
- INTERA 1.5T MRI SYSTEM - SENSE BREAST COIL
- INTERA 1.5T MRI SYSTEM - SENSE CARDIAC COILS
- INTERA 1.5T MRI SYSTEM - SENSE FLEX COIL
- INTERA 1.5T MRI SYSTEM - SENSE PERIPHERAL/VASCULAR COIL
- INTERA 1.5T MRI SYSTEM - SENSE XL TORSO COIL
- INTERA 1.5T MRI SYSTEM - SPINE COIL
- INTERA 1.5T MRI SYSTEM - SYNERGY NECK/HEAD COIL
- INTERA 1.5T MRI SYSTEM - SYNERGY PAEDIATRIC COIL
- INTERA 1.5T MRI SYSTEM - SYNERGY PERIPHERAL COIL
- INTERA 1.5T MRI SYSTEM- SENSE HEAD/NECK COIL
- INTERA 1.5T POWER MR
- UPGRADES ACHIEVA/LNTERA TO R5.7
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.