Medical device licence · 91891 · Class 2
XMARU MEDICAL IMAGE PROCESSING UNIT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 28, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91891
- Licence holder
- Rayence Co., Ltd.Hwaseong-Si, GD, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 28, 2013
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AC/DC ADAPTER
- BATTERY CHARGER
- LI-ION BATTERY
- MEDICAL IMAGE PROCESSING SOFTWARE
- MEDICAL IMAGE PROCESSING UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.