Medical device licence · 107054 · Class 2
SWOOP PORTABLE MRI SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 29, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107054
- Licence holder
- Hyperfine, Inc.Guilford, CT, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 29, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SWOOP MRI QUALITY ASSURANCE PHANTOM
- SWOOP POINT-OF-CARE MAGNETIC RESONANCE IMAGING DEVICE
- SWOOP POINT-OF-CARE MAGNETIC RESONANCE IMAGING SCANNER
- SWOOP TRANSMIT & RECEIVE RADIO FREQUENCY HEAD COIL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.