Medical device licence · 76264 · Class 3
AQUILION ONE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 7, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76264
- Licence holder
- Canon Inc.Tokyo, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 7, 2008
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AQUILION ONE SYSTEM - CONSOLE
- AQUILION ONE SYSTEM - DAS/DETECTOR
- AQUILION ONE SYSTEM - GANTRY
- AQUILION ONE SYSTEM - MAIN UNIT
- AQUILION ONE SYSTEM - OPTIONAL SOFTWARE
- AQUILION ONE SYSTEM - POWER DISTRIBUTOR
- AQUILION ONE SYSTEM - SOFTWARE
- AQUILION ONE SYSTEM - SOFTWARE UPGRADE KIT
- AQUILION ONE SYSTEM - X-RAY GENERATOR
- AQUILION ONE SYSTEM - X-RAY TUBE
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 “aquilion”. A notice may cover another product or only some lots: read it to see what it covers.
- Aquilion ONE Vision, Aquilion PRIME (2019-02-19)March 8, 2019 · Medical devices · Medical devices · Type II
- AQUILION PRIME MULTISLICE HELICAL CT SCANNEROctober 6, 2016 · Medical devices · Medical devices · Type II
- Aquilion One System (2015-06-11)July 9, 2015 · Medical devices · Health products · Type II
- AQUILION ONE SYSTEM (2015-01-06)April 13, 2015 · Medical devices · Health products · Type II
- Aquilion ONE System - Software (2014-08-12)September 9, 2014 · Medical devices · Medical devices · Type II
- Aquilion Systems (2013-09-09)October 16, 2013 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.