Medical device licence · 97222 · Class 3
4SIGHT
Yes: licensed in Canada
Licence status Issued (active); first licensed July 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97222
- Licence holder
- Accutome Inc. AlsoMalvern, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 4, 2016
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 4SIGHT A-SCAN PROBE
- 4SIGHT B-SCAN PROBE
- 4SIGHT CONTROL UNIT
- 4SIGHT PACHYMETER PROBE
- FOOTSWITCH
- UBM PROBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.