Medical device licence · 61696 · Class 3
TOMOTHERAPY TREATMENT SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 30, 2003; ended October 24, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61696
- Licence holder
- Accuray, Inc.Madison, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 30, 2003
- Ended
- October 24, 2022
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HI-ART GANTRY
- HI-ART LOCATION DISPLAY UNIT
- HI-ART OPERATOR STATION
- HI-ART PATIENT SUPPORT (COUCH)
- HI-ART POWER DISTRIBUTION UNIT
- HI-ART SYSTEM - BEAM MEASUREMENT AND QA PACKAGE
- HI-ART SYSTEM - FILM DIGITIZER KIT
- HI-ART SYSTEM - KIT-POWER
- HI-ART SYSTEM - MAIN UNIT
- HI-ART SYSTEM - PLANNING STATION
- HI-ART SYSTEM - STATUS CONSOLE
- HI-ART SYSTEM - TOMOPORTAL HARDWARE
- HI-ART SYSTEM - TOMOSCANNER AND PC KIT
- TOMOTHERAPY TREATMENT SYSTEM - BEAM MEASUREMENT AND QA PACKAGE
- TOMOTHERAPY TREATMENT SYSTEM - DICOM TRANSIT EXPORT
- TOMOTHERAPY TREATMENT SYSTEM - DOSE CONTROL SYSTEM (DCS)
- TOMOTHERAPY TREATMENT SYSTEM - EXTENDED NETWORK SYSTEM UPGRADE
- TOMOTHERAPY TREATMENT SYSTEM - FILM DIGITIZER KIT
- TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
- TOMOTHERAPY TREATMENT SYSTEM - MAIN UNIT
- TOMOTHERAPY TREATMENT SYSTEM - NETWORK STORAGE
- TOMOTHERAPY TREATMENT SYSTEM - PATIENT DATA TRANSFER
- TOMOTHERAPY TREATMENT SYSTEM - START SOFTWARE PACKAGE
- TOMOTHERAPY TREATMENT SYSTEM - TOMO QUALITY ASSURANCE (TQA) TOTAL PACKAGE
- TOMOTHERAPY TREATMENT SYSTEM - TOMOH
- TOMOTHERAPY TREATMENT SYSTEM - TOMOHD
- TOMOTHERAPY TREATMENT SYSTEM - TOMOHDA
- TOMOTHERAPY TREATMENT SYSTEM - TOMOPORTAL HARDWARE
- TOMOTHERAPY TREATMENT SYSTEM - TOMOSCANNER AND PC KIT
- TOMOTHERAPY TREATMENT SYSTEM - VOLO OPTIMIZATION CLUSTER
- TOMOTHERAPY TREATMENT SYSTEM-STATRT SOFTWARE PACKAGE
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 “tomotherapy”. A notice may cover another product or only some lots: read it to see what it covers.
- TomoTherapy Treatment System - Main Unit (2017-11-22)December 8, 2017 · Medical devices · Medical devices · Type II
- TomoTherapy Treatment System H-series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1) (2014-07-17)August 28, 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.