ApprovalTrail

Medical device licence · 71033 · Class 2

SENTINELLE BREAST SOFTWARE SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed April 5, 2006; ended September 23, 2022. It is in Health Canada’s archive of licences no longer in force.
Licence number
71033
Licence holder
Hologic, Inc.Sunnyvale, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
April 5, 2006
Ended
September 23, 2022
Devices covered
12

Devices on this licence

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

  • AEGIS BREAST BIOPSY PLUG-IN
  • AEGIS BREAST PLUG-IN
  • AEGIS LAPTOP
  • AEGIS MULTI-MODALITY BASE PLATFORM
  • AEGIS STANDALONE OR WEB VERSION
  • AEGIS WITH BRIGHT
  • HOLOGIC MULTIVIEW
  • SENTINELLE BREAST SOFTWARE SYSTEM
  • SENTINELLE BREAST SOFTWARE SYSTEM - BASIC
  • SENTINELLE BREAST SOFTWARE SYSTEM - CADVANTAGE SOFTWARE BASIC UPGRADE
  • SENTINELLE BREAST SOFTWARE SYSTEM WITH WORKSTATION
  • SENTINELLE BREAST SOFTWARE SYSTEM WITH WORKSTATION - BASIC

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