ApprovalTrail

Medical device licence · 98801 · Class 2

VANTAGE GALAN 3T

Yes: licensed in Canada

Licence status Issued (active); first licensed March 10, 2017. It is in Health Canada’s list of active licences.
Licence number
98801
Licence holder
Canon Inc.Tokyo, Japan
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
March 10, 2017
Devices covered
63

Devices on this licence

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

  • 10GBE HIGH SPEED RECONSTRUCTION KIT
  • ADVANCED IMAGE RECONSTRUCTION UNIT
  • ADVANCED INTELLIGENT CLEAR-IQ ENGINE (AICE) FOR MR
  • APPS FOR TABLET UX
  • AUTO CONSULT BRAIN PACKAGE
  • AUTO PROTOCOL BRAIN APPLICATION
  • AUTO SCAN ASSIST CARDIAC PACKAGE
  • AUTO SCAN ASSIST EXP PACKAGE
  • AUTO SCAN ASSIST KNEE PACKAGE
  • AUTO SCAN ASSIST LIVER PACKAGE
  • AUTO SCAN ASSIST SPINE PACKAGE
  • CEILING CAMERA PACKAGE
  • COMPRESSED SPEEDER APPLICATION - 3D
  • EASYTECH EXP PACKAGE
  • EASYTECH LIVER PACKAGE
  • EASYTECH SPINE PACKAGE
  • FAST 3D FOR SSFP
  • FAST 3D FOR TOF
  • FAST 3D PACKAGE
  • FAT FRACTION QUANTIFICATION APPLICATION
  • FREE BREATHING DYNAMIC APPLICATION
  • HARDWARE OPTIONS - FOOT SWITCH UNIT
  • HARDWARE OPTIONS - SECOND CONSOLE
  • HIGHER ORDER SHIM KIT
  • ITERATIVE MOTION CORRECTION (IMC) APPLICATION
  • MART EXP APPLICATION
  • MCARDIAC PLUS PACKAGE
  • MORTHO EXP PACKAGE
  • MR ELASTOGRAPHY
  • NEUROLINE+ APPLICATION
  • OLEA NOVA+ SEQUENCE
  • OPTIONAL RF COILS
  • PCASL (PSEUDO-CONTINUOUS ASL) APPLICATION
  • PIANISSIMO ZEN APPLICATION
  • PIQE APPLICATION
  • PROSTATELINE+ APPLICATION
  • RDC DWI APPLICATION
  • RECEIVING CIRCUIT EXTENSION KIT
  • SOFTWARE OPTION - COMPRESSED SPEEDER APPLICATION
  • SOFTWARE OPTION - EASYTECH KNEE PACKAGE
  • SOFTWARE OPTION - FAST 3D FOR MVOX
  • SOFTWARE OPTION - MULTIBAND SPEEDER APPLICATION
  • SOFTWARE OPTION - QUICK STAR APPLICATION
  • SOFTWARE OPTION - SPINELINE+ APPLICATION
  • SOFTWARE OPTIONS - DICOM
  • SOFTWARE OPTIONS - MBODY PACKAGE
  • SOFTWARE OPTIONS - MBREAST PACKAGE
  • SOFTWARE OPTIONS - MCARDIAC PACKAGE
  • SOFTWARE OPTIONS - MNEURO PACKAGE
  • SOFTWARE OPTIONS - MORTHO PACKAGE
  • SOFTWARE OPTIONS - MVASCULAR PACKAGE
  • SOFTWARE OPTIONS - UTE APPLICATION
  • SOFTWARE UPGRADE PACKAGE (V7.0)
  • SOFTWARE UPGRADE PACKAGE (V8.0)
  • SOFTWARE UPGRADE PACKAGE (V9.0)
  • SOFTWARE VERSION
  • SYSTEM OPTION - AICE RECONSTRUCTION PROCESSING UNIT FOR MR
  • SYSTEM OPTION - SOFTWARE UPGRADE PACKAGE (V6.0) FOR VANTAGE GALAN3T
  • VANTAGE GALAN 3T - GANTRY
  • VANTAGE GALAN 3T - MAIN UNIT
  • W-SPINELINE+ APPLICATION
  • WIRELESS CARDIAC GATING SYSTEM
  • WIRELESS PERIPHERAL PULSE AND RESPIRATORY GATING SYSTEM

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