ApprovalTrail

Medical device licence · 101481 · Class 3

SYNCVISION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 20, 2018. It is in Health Canada’s list of active licences.
Licence number
101481
Licence holder
Volcano CorporationSan Diego, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 20, 2018
Devices covered
4

Devices on this licence

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

  • SW UPGRADE KIT, SYNCVISION V4.2
  • SYNCVISION JOYSTICK
  • SYNCVISION SYSTEM
  • UPGRADE KIT, SYNCVISION V4.1

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “syncvision”. A notice may cover another product or only some lots: read it to see what it covers.

  • Syncvision SystemDecember 23, 2021 · Radiology · Inaccurate test or measurement results · Type II

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