Medical device licence · 96846 · Class 3
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 15, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96846
- Licence holder
- Vatech Co., Ltd.Hwaseong-Si, GD, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 15, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PAX-I3D SMART OP (COMPUTED TOMOGRAPHY X-RAY SYSTEM)
- PAX-I3D SMART OS (COMPUTED TOMOGRAPHY X-RAY SYSTEM)
- PAX-I3D SMART SC (COMPUTED TOMOGRAPHY X-RAY SYSTEM)
- PAX-I3D SMART SP (COMPUTED TOMOGRAPHY X-RAY SYSTEM)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.