Medical device licence · 93010 · Class 3
AQUILION TSX-201A
Yes: licensed in Canada
Licence status Issued (active); first licensed March 20, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93010
- Licence holder
- Canon Inc.Tokyo, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 20, 2014
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AQUILION TSX-201A - CONSOLE
- AQUILION TSX-201A - DAS/DETECTOR
- AQUILION TSX-201A - DISPLAY CONSOLE KIT
- AQUILION TSX-201A - GANTRY
- AQUILION TSX-201A - MAIN UNIT
- AQUILION TSX-201A - REAR FOOTSWITCHES
- AQUILION TSX-201A - SOFTWARE
- AQUILION TSX-201A - SURE FLUORO
- AQUILION TSX-201A - SURE XTENSION
- AQUILION TSX-201A - SYSTEM TRANSFORMER
- AQUILION TSX-201A - UPGRADE KIT
- AQUILION TSX-201A - X-RAY HIGH VOLTAGE GENERATOR
- AQUILION TSX-201A - 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
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.