ApprovalTrail

Medical device licence · 103593 · Class 2

OPTICAL COHERENCE TOMOGRAPHY OCT-A1

Yes: licensed in Canada

Licence status Issued (active); first licensed September 13, 2019. It is in Health Canada’s list of active licences.
Licence number
103593
Licence holder
Canon Inc.Tokyo, Japan
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
September 13, 2019
Devices covered
6

Devices on this licence

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

  • ANTERIOR SEGMENT ADAPTOR ASA-1
  • EXTERNAL EYE FIXATION LAMP
  • OPTICAL COHERENCE TOMOGRAPHY
  • RX CAPTURE FOR OCT-A1
  • RX SERVER
  • RX VIEWER

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