Medical device licence · 108479 · Class 2
OWANDY-RX PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed October 31, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108479
- Licence holder
- Owandy RadiologyCroissy-Beaubourg, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 31, 2022
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXPOSURE CONTROL BUTTON - ECB
- EXPOSURE SWITCH (SPIR CABLE + BUTTON)
- EXTERNAL LIGHT
- MOBILE STAND
- OWANDY-RX PRO CORE KIT SC NO BRACKET
- OWANDY-RX PRO TOP 110 SHORT CONE, INTERF WALL PLATE (16")
- OWANDY-RX PRO TOP 40 SHORT CONE, INTERF WALL PLATE (16")
- OWANDY-RX PRO TOP 80 SHORT CONE, INTERF WALL PLATE (16")
- RXINT PCB KIT
- RXLAT PCB KIT
- SHORT CIRCULAR CONE
- WALL PLATE INTERFACE
- X-RAY CONTROL UTILITY
- X-RAY SOURCE ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.