Medical device licence · 63186 · Class 3
ONCENTRA PROSTATE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 12, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 63186
- Licence holder
- Nucletron B.V.Veenendaal, Netherlands
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 12, 2003
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ONCENTRA PROSTATE SYSTEM - ADAPTER
- ONCENTRA PROSTATE SYSTEM - ECRM
- ONCENTRA PROSTATE SYSTEM - SOFTWARE
- ONCENTRA PROSTATE SYSTEM - STEPPER ENCODERS
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 “oncentra”. A notice may cover another product or only some lots: read it to see what it covers.
- Oncentra BrachyDecember 13, 2022 · Radiology · Performance · Type II
- ONCENTRA EXTERNAL BEAM / ONCENTRA BRACHYOctober 29, 2021 · Radiology · Software defect · Type II
- Oncentra External Beam/Oncentra Brachy 4.5September 5, 2017 · Medical devices · Type II
- Oncentra External Beam/Oncentral Brachy 4.5January 12, 2017 · Medical devices · Medical devices · Type II
- ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5 (2015-12-18)January 18, 2016 · Medical devices · Health products · Type II
- Oncentra External Beam/Oncentra Brachy 4.3 (2015-05-21)June 15, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.