Medical device licence · 83471 · Class 3
RAYSTATION
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83471
- Licence holder
- Raysearch Laboratories Ab (Publ)Stockholm, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- July 28, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAYCOMMAND
- RAYPLAN
- RAYSTATION
- RAYTREAT
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 “raystation”. A notice may cover another product or only some lots: read it to see what it covers.
- RayStationApril 11, 2024 · Radiology · Performance · Type II
- RaystationMarch 8, 2024 · Radiology · Performance · Type II
- RaystationMay 16, 2023 · General hospital and personal use - Radiology · Performance · Type II
- Raystation 4-11bMarch 14, 2022 · Radiology · Software defect · Type II
- RayStation (2020-05-17)June 5, 2020 · Medical devices · Medical devices · Type II
- RayStation (2020-03-04)April 16, 2020 · Medical devices · Medical devices · Type II
- RayStation (2019-12-18)January 24, 2020 · Medical devices · Medical devices · Type II
- RayStation & RayPlan (2019-11-18)January 20, 2020 · Medical devices · Medical devices · Type II
- RayStation (2018-11-10)November 30, 2018 · Medical devices · Medical devices · Type III
- RayStation (2018-09-18)October 19, 2018 · Medical devices · Medical devices · Type II
- RayStation and RayPlan (2018-06-29)July 19, 2018 · Medical devices · Medical devices · Type II
- RayStation, RayPlan, and InverseArc 1.0 (2018-06-06)June 22, 2018 · Medical devices · Medical devices · Type II
- RayStation and RayPlan (2018-01-26)March 13, 2018 · Medical devices · Medical devices · Type III
- RAYSTATION (2017-11-20)November 30, 2017 · Medical devices · Medical devices · Type II
- RaystationFebruary 14, 2017 · Medical devices · Type II
- RAYSTATIONSeptember 1, 2016 · Medical devices · Type III
- RAYSTATION (2016-07-01)July 19, 2016 · Medical devices · Medical devices · Type II
- RAYSTATION (2016-02-12)March 10, 2016 · Medical devices · Medical devices · Type II
- Raystation (2015-05-08)June 15, 2015 · Medical devices · Health products · Type II
- RAYSTATION (2015-03-04)April 13, 2015 · Medical devices · Health products · Type II
- Raystation (2014-09-17)October 2, 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.