Medical device licence · 104237 · Class 2
DRX-EVOLUTION DIGITAL RADIOGRAPHY SYSTEM SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104237
- Licence holder
- Carestream Healthcare International Company LimitedShanghai, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 31, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIG TOMO UPG OPTION
- DIG TOMO UPG OPTION SERVICE
- DRX-EVOLUTION AUO & SCB UPGRADE KIT
- DRX-EVOLUTION SCB UPGRADE KIT
- DUAL ENERGY UPG OPT SERVICE
- DUAL ENERGY UPG OPTION
- DV V5.X TO IV V1.X SW UPG FOR EVO
- SMART NOISE CANCELLATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.