ApprovalTrail

Medical device licence · 67333 · Class 3

SOPHIE CLASSIC

No longer licensed: cancelled

Licence status Cancelled; first licensed February 7, 2005; ended July 29, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
67333
Licence holder
Planmed OyHelsinki, Finland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 7, 2005
Ended
July 29, 2021
Devices covered
8

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - BUCKY
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - CYTOGUIDE
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - DIGIGUIDE
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - FILM MARKER
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - FLEX-AEC
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - MAIN UNIT
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - MAXVIEW
  • SOPHIE CLASSIC MAMMOGRAPHY X-RAY SYSTEM - RADIATION PROTECTION SCREEN

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.