Medical device licence · 80484 · Class 2
DRX-EVOLUTION DIGITAL RADIOGRAPHY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 17, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80484
- Licence holder
- Carestream Healthcare International Company LimitedShanghai, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 17, 2009
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRX-EVOLUTION ASSY-SMART ROOM FOR EVO PLUS
- DRX-EVOLUTION ASSY-VIDEO ASSIST FOR EVO PLUS
- DRX-EVOLUTION AUDIO ASSIST
- DRX-EVOLUTION NO SYSTEM WITH NON-MOTORIZED OTC
- DRX-EVOLUTION NON-MOTORIZED OTC
- DRX-EVOLUTION PATIENT POSITION MONITORING
- DRX-EVOLUTION PLUS CURVED RAIL FOR DRX-EVOLUTION AND WALL STAND
- DRX-EVOLUTION PLUS POWERREADY DOCK
- DRX-EVOLUTION PLUS SMART ROOM ASSIST
- DRX-EVOLUTION PLUS SMART ROOM ASSIST W/O VLLI
- DRX-EVOLUTION PLUS SMART ROOM W/O VLLI
- DRX-EVOLUTION PLUS VIRTUAL COLLIMATION
- DRX-EVOLUTION PLUS VIRTUAL LONG LENGTH IMAGING
- DRX-EVOLUTION SMART AUTO POSITION
- DRX-EVOLUTION SMART COLLIMATION
- DRX-EVOLUTION SMART PATIENT POSITIONING
- DRX-EVOLUTION SMART TECHNIQUE
- DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
- DRX-EVOLUTION SYSTEM AUTOMATIC WITH MOTORIZATION
- DRX-EVOLUTION SYSTEM HYBRID WITH SEMI MOTORIZATION
- DRX-EVOLUTION SYSTEM WITH MOTORIZATION-FIXED WALL DETECTOR
- DRX-EVOLUTION/MOTORIZED OTC-FF WALLSTAND
- DRX-EVOLUTION/PREMIUM OTC-FF WALLSTAND-NO TABLE-1DRXGOS
- DRX-EVOLUTION/PREMIUM OTC-FF WALLSTAND-PREMIUM TABLE-1DRXGOS
- DRX-EVOLUTION/PREMIUM OTC-FF WALLSTAND-PREMIUM TABLE-2DRXGOS
- DRX-EVOLUTION/PREMIUM OTC-NO WALLSTAND-PREMIUM TABLE-1DRXGOS
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 “drx-evolution”. A notice may cover another product or only some lots: read it to see what it covers.
- DRX-EVOLUTION MOTORIZED WALLSTAND/DETECTOR (2015-08-04)September 1, 2015 · Medical devices · Health products · Type II
- DRX-Evolution SystemSeptember 17, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.