{
  "format": "devicerts.device.v1",
  "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).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/raystation-11-0-muj",
    "json_url": "https://devicerts.com/devices/raystation-11-0-muj.json",
    "markdown_url": "https://devicerts.com/devices/raystation-11-0-muj.md",
    "publisher": "deviCERTS (devicerts.com)",
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      {
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        "url": "https://open.fda.gov/apis/device/510k/"
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        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "device": {
    "name": "RayStation 11.0",
    "registry_name": "RayStation 11.0",
    "url": "https://devicerts.com/devices/raystation-11-0-muj",
    "manufacturer": {
      "name": "RaySearch Laboratories AB (PUBL)",
      "url": "https://devicerts.com/manufacturers/raysearch-laboratories-ab-publ",
      "country": "Sweden",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
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    "classification": [
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          {
            "value": "K211867",
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    "product_codes": [
      "MUJ"
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    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
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      "number": "K211867",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-09-08",
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  ],
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  "certificates": [],
  "recalls": [
    {
      "number": "Z-1103-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-11-28",
      "reason": "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.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-2491-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-08-08",
      "reason": "DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-1189-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-01-16",
      "reason": "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.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-1748-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-03-28",
      "reason": "Potential for reported SSD to be too high.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-1482-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-02-23",
      "reason": "A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-0850-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2022-02-11",
      "reason": "Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-0732-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-12-30",
      "reason": "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",
      "applies": "this device",
      "via": "K211867"
    },
    {
      "number": "Z-0849-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-09-22",
      "reason": "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",
      "applies": "this device",
      "via": "K211867"
    }
  ],
  "eu_market_availability": null,
  "properties": [
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        },
        {
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}