ApprovalTrail

Medical device licence · 103867 · Class 3

ZENITION 70

Yes: licensed in Canada

Licence status Issued (active); first licensed November 19, 2019. It is in Health Canada’s list of active licences.
Licence number
103867
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
November 19, 2019
Devices covered
4

Devices on this licence

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

  • FLAT DETECTOR FD12
  • FLAT DETECTOR FD15
  • FLAT DETECTOR FD17
  • ZENITION 70

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 “zenition”. 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.