ApprovalTrail

Medical device licence · 101100 · Class 3

AQUILION PRECISION MODEL TSX-304A

Yes: licensed in Canada

Licence status Issued (active); first licensed May 25, 2018. It is in Health Canada’s list of active licences.
Licence number
101100
Licence holder
Canon Inc.Tokyo, Japan
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 25, 2018
Devices covered
21

Devices on this licence

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

  • AQUILION PRECISION (TSX-304A) SYSTEM - MAIN UNIT
  • CANON RECONSTRUCTION PROCESSING UNIT
  • CONSOLE
  • CONSOLE UPGRADE KIT
  • COUCH LATERAL MOVEMENT UNIT
  • CT SCANNER AQUILION PRECISION
  • DAS/DETECTOR
  • DUAL ENERGY COMPOSITION ANALYSIS
  • DUAL ENERGY SYSTEM
  • FIRST
  • GANTRY
  • HANDY SNAP
  • INJECTOR SYNCHRONIZATION SYSTEM
  • LCD MONITOR FOR SUREFLUORO
  • MAIN SOFTWARE
  • POWER DISTRIBUTOR
  • REAR OPERATING PANEL KIT
  • RESPIRATORY-GATED SCAN SYSTEM
  • SOFTWARE OPTION
  • SUREFLUORO
  • X-RAY GENERATOR

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 “aquilion”. A notice may cover another product or only some lots: read it to see what it covers.

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