# RayStation 11.0 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [RaySearch Laboratories AB (PUBL)](https://devicerts.com/manufacturers/raysearch-laboratories-ab-publ) (Sweden) - Device class: Class II (US FDA) - FDA product code: MUJ ## Registrations and authorizations - **510(k)** · FDA 510(k) · United States · K211867 · decision 2021-09-08 · decision SESE · status: Active ## Recalls - Z-1103-2026 · Class II · ongoing · initiated 2025-11-28: 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. - Z-2491-2025 · Class II · ongoing · initiated 2025-08-08: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. - Z-1189-2025 · Class II · ongoing · initiated 2025-01-16: 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. - Z-1748-2024 · Class II · ongoing · initiated 2024-03-28: Potential for reported SSD to be too high. - Z-1482-2024 · Class II · ongoing · initiated 2024-02-23: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. - Z-0850-2022 · Class II · ongoing · initiated 2022-02-11: Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. - Z-0732-2022 · Class II · ongoing · initiated 2021-12-30: 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 - Z-0849-2022 · Class II · ongoing · initiated 2021-09-22: 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 ## Identifiers - 510(k) Number: K211867 [FDA 510(k)] - FDA product code: MUJ [FDA 510(k)] ## Classification - Device class: Class II [FDA 510(k)] - Regulation: 21 CFR Part 892.5050 [FDA 510(k)] - Advisory committee: Radiology [FDA 510(k)] - FDA decision: SESE [FDA 510(k)] ## Source and citation - Cite as: RayStation 11.0, RaySearch Laboratories AB (PUBL). deviCERTS medical device catalogue. https://devicerts.com/devices/raystation-11-0-muj (data as of 2026-11-14). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/raystation-11-0-muj - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.