ApprovalTrail

Medical device licence · 67514 · Class 3

SOPHIE MOBILE

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 17, 2005; ended August 24, 2012. It is in Health Canada’s archive of licences no longer in force.
Licence number
67514
Licence holder
Planmed OyHelsinki, Finland
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 17, 2005
Ended
August 24, 2012
Devices covered
8

Devices on this licence

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

  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - BUCKY
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - CYTOGUIDE
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - DIGIGUIDE
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - FILM MARKER
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - FLEX-AEC
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - MAIN UNIT
  • SOPHIE MOBILE MAMMOGRAPHY X-RAY SYSTEM - MAXVIEW
  • SOPHIE MOBILE MAMMOGRPAHY 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.