Medical device licence · 106982 · Class 2
SKANRAD 400
Yes: licensed in Canada
Licence status Issued (active); first licensed November 17, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106982
- Licence holder
- Skanray Technologies LimitedMysore, KA, India
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 17, 2021
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXTERNAL STAND CONSOLE ASSY
- FLAT PANEL DETECTOR
- FRU ELEVATION TABLE
- HANDHELD CONSOLE ASSEMBLY SKANRAD 400
- LED COLLIMATOR ASMSKANRAD 400
- SG400 HV TANK ASSY
- SKANGEN 32HF X-RAY GENERATOR
- SKANRAD 400
- SOFTWARE LICENSE
- TUBE HEAD ASSY WITH COLLIMATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.