ApprovalTrail

Medical device licence · 73260 · Class 3

BRILLIANCE 64 SLICE COMPUTED TOMOGRAPHY SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 8, 2007; ended October 29, 2015. It is in Health Canada’s archive of licences no longer in force.
Licence number
73260
Licence holder
Philips Medical Systems Nederland B.V.Orange Village, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 8, 2007
Ended
October 29, 2015
Devices covered
12

Devices on this licence

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

  • BRILLIANCE 64 SLICE CT SYSTEM - COLLIMATOR
  • BRILLIANCE 64 SLICE CT SYSTEM - DMS ASSEMBLY
  • BRILLIANCE 64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE (EBW)
  • BRILLIANCE 64 SLICE CT SYSTEM - GANTRY
  • BRILLIANCE 64 SLICE CT SYSTEM - HEARTBEAT-CS PRO PKG.
  • BRILLIANCE 64 SLICE CT SYSTEM - LASER ASSEMBLY
  • BRILLIANCE 64 SLICE CT SYSTEM - MAIN UNIT
  • BRILLIANCE 64 SLICE CT SYSTEM - MASTERMATCH IMAGE FUSION
  • BRILLIANCE 64 SLICE CT SYSTEM - MONITOR
  • BRILLIANCE 64 SLICE CT SYSTEM - OPERATOR CONSOLE
  • BRILLIANCE 64 SLICE CT SYSTEM - PATIENT COUCH
  • BRILLIANCE 64 SLICE CT SYSTEM - X-RAY TUBE

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 “brilliance”. 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.