Medical device licence · 100687 · Class 3
PLANMED CLARITY
Yes: licensed in Canada
Licence status Issued (active); first licensed March 7, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100687
- Licence holder
- Planmed OyHelsinki, Finland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 7, 2018
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLAT PANEL DETECTOR, 2D
- FLAT PANEL DETECTOR, 3D
- PLANMED CLARITY 2D FULL FIELD
- PLANMED CLARITY 3D DIGITAL BREAST TOMOSYNTHESIS X-RAY UNIT
- PLANMED CLARITY GUIDE
- PLANMED CLARITY S
- PLANMED ENVISION PRO REVIEW WORKSTATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.