ApprovalTrail

Medical device licence · 95621 · Class 2

FFRCT

Yes: licensed in Canada

Licence status Issued (active); first licensed August 19, 2015. It is in Health Canada’s list of active licences.
Licence number
95621
Licence holder
Heartflow, Inc.San Francisco, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 19, 2015
Devices covered
2

Devices on this licence

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

  • FFRCT
  • FFRCT MOBILE

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