RayStation
Model 11B SPT1 · Raysearch Laboratories AB (Publ) · DI 07350002010570
MUJ — System, Planning, Radiation Therapy Treatment · Class II · 21 CFR 892.5050
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (6)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-11-28 | Z-1104-2026 | Class II | Open, Classified | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. | code info di |
| 2025-08-08 | Z-2492-2025 | Class II | Open, Classified | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. | code info di |
| 2025-01-16 | Z-1190-2025 | Class II | Open, Classified | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs. | code info di |
| 2024-03-28 | Z-1749-2024 | Class II | Open, Classified | Potential for reported SSD to be too high. | code info di |
| 2024-02-23 | Z-1482-2024 | Class II | Open, Classified | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. | code info di |
| 2022-06-10 | Z-1299-2022 | Class II | Terminated | This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.14 |
| 2019-06 | 0 | 2.29 |
| 2019-07 | 0 | 1.14 |
| 2019-08 | 0 | 1.57 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1.14 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1.14 |
| 2020-03 | 0 | 4.57 |
| 2020-04 | 0 | 2.29 |
| 2020-05 | 0 | 1.14 |
| 2020-07 | 0 | 2.13 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1.14 |
| 2020-11 | 0 | 2 |
| 2021-07 | 0 | 2.29 |
| 2021-08 | 0 | 2.29 |
| 2021-10 | 0 | 1.71 |
| 2021-12 | 0 | 1.5 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-06 | 0 | 2 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1 |
| 2022-11 | 0 | 1.33 |
| 2022-12 | 0 | 1.5 |
| 2023-01 | 0 | 1.14 |
| 2023-03 | 0 | 2.5 |
| 2023-04 | 0 | 1.67 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.2 |
| 2023-12 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-10 | 0 | 1.5 |
| 2025-02 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-06 | 0 | 1 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-06 | 0 | 1 |
Regulatory clearances
- K220141 SESE 2022-04-15 (k number procode)
Predicate lineage
K220141 — cites (transitively): K211867 (d1), K210645 (d2), K181145 (d3), K200569 (d3), K203172 (d3), K172163 (d4), K190387 (d4), K183034 (d4), K141248 (d5), K170969 (d5), K141572 (d5), K162393 (d5), K180379 (d5), K133227 (d6), K080601 (d6), K123230 (d6), K092871 (d6), K102915 (d6), K111106 (d6), K111862 (d6), K152393 (d6), K171536 (d6), K102011 (d7), K112778 (d7), K141283 (d7), K170355 (d7), K071873 (d8), K083591 (d8), K131891 (d8), K133247 (d8), K160093 (d8) — cited as predicate by K222312, K232514, K250780, K252109
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Raysearch Laboratories AB (Publ)
- OAI 2022-11-17 RAYSEARCH LABORATORIES AB · 5 citations