Medical device licence · 98689 · Class 3
MOBETRON
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed February 23, 2017; ended September 5, 2024. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 98689
- Licence holder
- Intraop Medical CorporationSunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 23, 2017
- Ended
- September 5, 2024
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- APPLICATOR
- APPLICATOR KIT
- APPLICATOR MIRROR & CLAMP ASSY.
- BEAM SPREADER
- BOLUS
- BOLUS KIT
- CABLE ASSY
- COLLIMATOR CAP
- HAND CONTROL
- KIT, AUXILIARY BEAMSTOPPER
- KIT, SYSTEM CABLES
- LASER ALIGNMENT QA DEVICE
- LEAD ARRAY
- MOBETRON
- QA APPLICATOR ASSEMBLY
- SARCOMA APPLICATOR
- SARCOMA APPLICATOR KIT
- SHIELD COVER
- SHIELD, SST
- STANDARD POWER CORD
- STERILIZABLE COLLIMATOR CAP SET
- THIN WALL APPLICATOR TUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.