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RayStation

by RaySearch Laboratories AB (PUBL) 4 variants

510(k) K200569

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200569 Date24 Sep 2020ClearedStatusActive

Official records

Recalls

14 recalls · 6 ongoing · FDA

    • Ongoing Z-2489-2025 FDA Class II initiated 8 Aug 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.

    • Ongoing Z-1187-2025 FDA Class II initiated 16 Jan 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 density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

  • 2 recalls, same reason

    • Ongoing Z-1745-2024 FDA Class II initiated 28 Mar 2024
    • Ongoing Z-1746-2024 FDA Class II initiated 28 Mar 2024

    Potential for reported SSD to be too high.

    • Ongoing Z-1482-2024 FDA Class II initiated 23 Feb 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.

    • Ongoing Z-1427-2021 FDA Class II initiated 25 Mar 2021

    Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

    • Terminated Z-1403-2022 FDA Class II initiated 1 Jun 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.

    • Terminated Z-2138-2021 FDA Class II initiated 8 Jun 2021

    Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

    • Terminated Z-1838-2021 FDA Class II initiated 21 Apr 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 is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.

    • Terminated Z-1598-2021 FDA Class II initiated 7 Apr 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 course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

    • Terminated Z-1597-2021 FDA Class II initiated 22 Feb 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 part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

    • Terminated Z-2039-2023 FDA Class II initiated 22 Jan 2021

    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 incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

    • Terminated Z-0589-2021 FDA Class II initiated 11 Nov 2020

    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 RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

    • Terminated Z-0478-2021 FDA Class II initiated 8 Oct 2020

    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.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-1427-2021
  2. Recall initiated FDA recalls Z-1598-2021
  3. Recall initiated FDA recalls Z-1838-2021
  4. Recall initiated FDA recalls Z-2138-2021
  5. Recall initiated FDA recalls Z-1403-2022
  6. Recall initiated FDA recalls Z-1482-2024
  7. Recall initiated FDA recalls Z-1745-2024
  8. Recall initiated FDA recalls Z-1746-2024
  9. Recall initiated FDA recalls Z-1187-2025
  10. Recall initiated FDA recalls Z-2489-2025

5 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUJ
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

RayStation is a treatment planning system for radiation therapy treatment. It is a software device used in radiation therapy of cancer.

RayStation is supplied as a software system and is regulated under FDA 510(k) clearance with product code MUJ and regulation number 892.5050. It is classified as a Class II device and is used in radiology settings.

Devices cleared under K200569

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200569
UDI-DISize and differences
RayStation 9B SP1
RaySearch Laboratories AB (PUBL)
9B SP107350002010297 —On the market

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

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