ApprovalTrail

Medical device licence · 72908 · Class 3

SOFTSCAN OPTICAL BREAST IMAGING SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed December 13, 2006; ended October 31, 2013. It is in Health Canada’s archive of licences no longer in force.
Licence number
72908
Licence holder
Art Advanced Research Technologies Inc.Montreal, QC, Canada
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 13, 2006
Ended
October 31, 2013
Devices covered
6

Devices on this licence

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

  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - ACQUISITION UNIT
  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - ACQUISITION UNIT - CONTROL PANEL
  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - MAIN UNIT
  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - OPTICAL COMPENSATION MEDIUM (OCM)
  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - REVIEW WORKSTATION
  • SOFTSCAN OPTICAL BREAST IMAGING SYSTEM - REVIEW WORKSTATION APPL. SOFTWARE

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