System, Planning, Radiation Therapy Treatment
Raysearch Laboratories Ab (publ)'s record for this product code
MDR events115All time
Recalls0All time
510(k) clearances15All time
Recent MDR events
115 adverse event reports on file
- RAYCAREMay 22, 2026Malfunction3010034862-2026-00002
- RAYCAREMay 22, 2026Malfunction3007774465-2026-00002
- RAYCAREMay 19, 2026Malfunction3007774465-2026-00001
- RAYCAREMay 19, 2026Malfunction3010034862-2026-00001
- RAYSTATIONNov 27, 2025Malfunction3007774465-2025-00003
- RAYSTATIONNov 27, 2025Malfunction3010034862-2025-00003
- RAYSTATIONAug 14, 2025Malfunction3007774465-2025-00002
- RAYSTATIONAug 14, 2025Malfunction3010034862-2025-00002
- RAYSTATIONJan 16, 2025Malfunction3007774465-2025-00001
- RAYSTATIONJan 16, 2025Malfunction3010034862-2025-00001
Recalls
0 recall events for this product code
No recalls on file for Raysearch Laboratories Ab (publ) under this product code.
510(k) clearances
15 clearances for this product code
- K252109Dec 22, 2025
RayStation (2024A SP3)
- K242992Apr 17, 2025
RayCare (2024A SP1)
- K240398Apr 4, 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
- K222312Mar 29, 2023
RayStation 12A
- K220141Apr 15, 2022
RayStation 11B
- K211867Sep 8, 2021
RayStation 11.0
- K210645Jun 29, 2021
RayStation 10.1
- K200569Sep 24, 2020
RayStation
- K200487Jun 10, 2020
RayCare 3.1
- K191384Jul 8, 2019
RayCare 2.3