Medical device licence · 86402 · Class 3
DISCOVERY PET/CT 600 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86402
- Licence holder
- Ge Medical Systems, LlcWaukesha, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 22, 2011
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISCOVERY PET/CT 600 SYSTEM - 16 FPS UPGRADE
- DISCOVERY PET/CT 600 SYSTEM - 2 METER SCAN OPTION
- DISCOVERY PET/CT 600 SYSTEM - BASE CONFIGURATION
- DISCOVERY PET/CT 600 SYSTEM - CONSOLE UPGRADE
- DISCOVERY PET/CT 600 SYSTEM - FULL CONFIGURATION
- DISCOVERY PET/CT 600 SYSTEM - MAIN UNIT
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: ANZAI RESPIRATORY GATING INTERFACE
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: BASE OPTIONS
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: CARDIAC ACQC
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: ENHANCED XTREAM INJECTOR INTERFACE
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: MOTION MATCH
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: RADRX
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: SHARP IR
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: VARIAN RESPIRATORY GATING INTERFACE
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: WIDEVIEW
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE: XTREAM INJECTOR INTERFACE
- DISCOVERY PET/CT 600 SYSTEM - SOFTWARE:16SLICE OPTION
- DISCOVERY PET/CT 600 SYSTEM - UPGRADE TO RECONSTRUCTION COMPUTER (BLADE CENTER)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.