Medical device licence · 107376 · Class 3
OPTIS INTEGRATED NEXT IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 7, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107376
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 7, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTIS INTEGRATED NEXT IMAGING SYSTEM
- OPTIS INTEGRATED NEXT UPGRADE KIT
- OPTIS INTEGRATED PRE-INSTALLATION KIT
- ULTREON 2.0 SOFTWARE UPGRADE KIT
- ULTREON 3.0 SOFTWARE UPGRADE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.