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RayStation 8.1

by RaySearch Laboratories AB (PUBL)

RayStation 8.1 is a Class II device made by RaySearch Laboratories AB (PUBL), cleared under FDA 510(k) K190387 on 19 Jun 2019 and listed in FDA GUDID since 19 Sep 2019 (UDI-DI 07350002010129), active as of 23 Oct 2026. 32 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

510(k) K190387

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350002010129 UDI-DI Date19 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190387 Date19 Jun 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190387 decided 19 Jun 2019 Active
  • FDA GUDID UDI-DI 07350002010129 listed 19 Sep 2019 Listed

Recalls

32 recalls · 8 ongoing · FDA

    • Ongoing Z-2488-2025 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-1186-2025 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-1743-2024 FDA Class II initiated 28 Mar 2024
    • Ongoing Z-1744-2024 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-1281-2023 FDA Class II initiated 17 Feb 2023

    It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

    • Ongoing Z-2426-2020 FDA Class II initiated 26 May 2020

    It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

    • Ongoing Z-1598-2020 FDA Class II initiated 4 Mar 2020

    Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

  • 15 recalls, same reason

    • Terminated Z-2343-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2351-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2352-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2347-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2349-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2348-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2339-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2345-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2350-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2353-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2340-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2346-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2342-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2341-2020 FDA Class II initiated 18 May 2020
    • Terminated Z-2344-2020 FDA Class II initiated 18 May 2020

    Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

  • 7 recalls, same reason

    • Terminated Z-1465-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1463-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1464-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1468-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1462-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1467-2020 FDA Class II initiated 20 Feb 2020
    • Terminated Z-1466-2020 FDA Class II initiated 20 Feb 2020

    There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

    • Terminated Z-0866-2020 FDA Class II initiated 19 Dec 2019

    Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

    • Terminated Z-0736-2020 FDA Class II initiated 18 Nov 2019

    Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

Timeline

34 dated events

  1. Recall initiated FDA recalls Z-2342-2020
  2. Recall initiated FDA recalls Z-2341-2020
  3. Recall initiated FDA recalls Z-2344-2020
  4. Recall initiated FDA recalls Z-2426-2020
  5. Recall initiated FDA recalls Z-1281-2023
  6. Recall initiated FDA recalls Z-1482-2024
  7. Recall initiated FDA recalls Z-1743-2024
  8. Recall initiated FDA recalls Z-1744-2024
  9. Recall initiated FDA recalls Z-1186-2025
  10. Recall initiated FDA recalls Z-2488-2025

24 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

GUDID

Trade name
RayStation
Generic name
Radiation therapy software
Model / reference
8.1
Primary DI / UDI-DI
07350002010129
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Cleared under the same submission (K190387)

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from RaySearch Laboratories AB (PUBL)

See all devices from RaySearch Laboratories AB (PUBL) →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)