Medical device licence · 111520 · Class 3
AQUILION SERVE SP
Yes: licensed in Canada
Licence status Issued (active); first licensed July 18, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111520
- Licence holder
- Canon Inc.Tokyo, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 18, 2024
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONSOLE
- COUCH LATERAL MOVEMENT UNIT
- CT FLUOROSCOPY (SUREFLUORO)
- CT SCANNER AQUILION SERVE SP
- DAS/DETECTOR
- DISPLAY CONSOLE KIT
- DOUBLE SLICE KIT
- EXTENSION KIT FOR DISPLAY CONSOLE
- GANTRY
- GANTRY ILLUMINATION KIT
- INJECTOR SYNCHRONIZATION SYSTEM, CAN PROTOCOL CLASS 1
- KIT FOR WIDENING THE GAP BETWEEN GANTRY AND COUCH
- LCD MONITOR FOR SUREFLUORO
- PATIENT COUCH REPLACEMENT KIT
- POWER DISTRIBUTOR
- QA PHANTOM KIT
- REAR FOOTSWITCHES
- RECONSTRUCTION PROCESSING SYSTEM (AICE-I)
- RESPIRATORY-GATED SCAN SYSTEM
- SOFTWARE OPTION
- SOFTWARE VERSION
- X-RAY GENERATOR
- X-RAY HIGH-VOLTAGE GENERATOR
- X-RAY TUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.