Medical device licence · 64214 · Class 3
AQUILION SUPER 4 EDITION
No longer licensed: cancelled
Licence status Cancelled; first licensed April 22, 2004; ended March 4, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 64214
- Licence holder
- Canon Medical Systems CorporationOtawara-Shi, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 22, 2004
- Ended
- March 4, 2016
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AQUILION SUPER 4
- AQUILION SUPER 4 - 0.4MS SCAN UPGRADE
- AQUILION SUPER 4 - CARDIAC FUNCTION ANALYSIS
- AQUILION SUPER 4 - CONSOLE
- AQUILION SUPER 4 - DAS (DATA ACQUISITION SYSTEM) CONSOLE
- AQUILION SUPER 4 - DICOM COMPONENTS
- AQUILION SUPER 4 - ECG GATED
- AQUILION SUPER 4 - GANTRY
- AQUILION SUPER 4 - PATIENT OBSERVATION SYS
- AQUILION SUPER 4 - TUBE
- AQUILION SUPER 4 - XRAY GENERATOR
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.