# K200569: RayStation

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Sep 24, 2020 after 204 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K010975 (2001). 70 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190387: RayStation, RaySearch Laboratories AB (PUBL) (2019) Summary page 4.

## Most influential descendants
- K210645: RayStation 10.1 (2021), 5 descendants of its own
- K211867: RayStation 11.0 (2021), 4 descendants of its own
- K220141: RayStation 11B (2022), 3 descendants of its own
- K222312: RayStation 12A (2023), 2 descendants of its own
- K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (2025), 1 descendant of its own

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2489-2025: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- Jan 16, 2025 · Class II · Z-1187-2025: 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
- Mar 28, 2024 · Class II · Z-1746-2024: Potential for reported SSD to be too high.
- Mar 28, 2024 · Class II · Z-1745-2024: Potential for reported SSD to be too high.
- Feb 23, 2024 · Class II · Z-1482-2024: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
- Jun 1, 2022 · Class II · Z-1403-2022: An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
- Jun 8, 2021 · Class II · Z-2138-2021: Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
- Apr 21, 2021 · Class II · Z-1838-2021: Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices i
- Apr 7, 2021 · Class II · Z-1598-2021: When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment 
- Mar 25, 2021 · Class II · Z-1427-2021: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
- Feb 22, 2021 · Class II · Z-1597-2021: For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as
- Jan 22, 2021 · Class II · Z-2039-2023: A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are i
- Nov 11, 2020 · Class II · Z-0589-2021: Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RaySt
- Oct 8, 2020 · Class II · Z-0478-2021: If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

## Indications for use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K200569
Methodology: https://510kreport.com/methodology