ApprovalTrail

Medical device licence · 99217 · Class 3

AFFIRM PRONE BIOPSY SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed May 30, 2017. It is in Health Canada’s list of active licences.
Licence number
99217
Licence holder
Hologic, Inc.Sunnyvale, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 30, 2017
Devices covered
9

Devices on this licence

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

  • AFFIRM PRONE BIOPSY 3D UPGRADE
  • AFFIRM PRONE BIOPSY SYSTEM
  • AFFIRM PRONE BIOPSY SYSTEM - ACQUISITION WORK STATION
  • AFFIRM PRONE BIOPSY SYSTEM - AXL PADDLE
  • AFFIRM PRONE BIOPSY SYSTEM - GANTRY
  • AFFIRM PRONE BIOPSY SYSTEM - GENERATOR
  • AFFIRM PRONE BIOPSY SYSTEM - LTRL BIOPSY PADDLE
  • AFFIRM PRONE BIOPSY SYSTEM - STD BIOPSY PADDLE
  • MID-FIELD TOMOGRAPHIC MAMMOGRAPHY DETECTOR

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