ApprovalTrail

Medical device licence · 73772 · Class 2

QUANTIFICATION SOFTWARE FOR X-RAY IMAGE POST-PROCESSING

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed April 13, 2007; ended June 3, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
73772
Licence holder
Medis Medical Imaging Systems B.V.Leiden, Netherlands
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
April 13, 2007
Ended
June 3, 2025
Devices covered
3

Devices on this licence

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

  • MEDIS SUITE
  • QANGIO XA
  • QANGIO XA 3D

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 “quantification”. 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.