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RayStation 11.0

by RaySearch Laboratories AB (PUBL)

510(k) K211867

RayStation 11.0 is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by RaySearch Laboratories AB (PUBL), cleared under FDA 510(k) K211867 on 8 Sep 2021, active as of 22 Oct 2026. 8 FDA recalls are linked to it.

Active United States

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

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 NumberK211867 Date8 Sep 2021ClearedStatusActive

Official records

Recalls

8 recalls · 8 ongoing · FDA

    • Ongoing Z-1103-2026 FDA Class II initiated 28 Nov 2025

    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.

    • Ongoing Z-2491-2025 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-1189-2025 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.

    • Ongoing Z-1748-2024 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-0850-2022 FDA Class II initiated 11 Feb 2022

    Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

    • Ongoing Z-0732-2022 FDA Class II initiated 30 Dec 2021

    If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

    • Ongoing Z-0849-2022 FDA Class II initiated 22 Sep 2021

    An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

Timeline

9 dated events

  1. Cleared FDA 510(k) K211867
  2. Recall initiated FDA recalls Z-0849-2022
  3. Recall initiated FDA recalls Z-0732-2022
  4. Recall initiated FDA recalls Z-0850-2022
  5. Recall initiated FDA recalls Z-1482-2024
  6. Recall initiated FDA recalls Z-1748-2024
  7. Recall initiated FDA recalls Z-1189-2025
  8. Recall initiated FDA recalls Z-2491-2025
  9. Recall initiated FDA recalls Z-1103-2026

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

Devices cleared under K211867

3 devices · 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 K211867
UDI-DISize and differences
RayStation 11.0
RaySearch Laboratories AB (PUBL)
11.007350002010389 —On the market
RayStation 11.0.1
RaySearch Laboratories AB (PUBL)
11.0.107350002010433 —On the market
RayStation 11A SP2
RaySearch Laboratories AB (PUBL)
11A SP207350002010440 —On the market

Similar devices

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

Other devices from RaySearch Laboratories AB (PUBL)

See all devices from RaySearch Laboratories AB (PUBL) →