{
  "format": "devicerts.device.v1",
  "cite_as": "Raystation Version 1.0, Raysearch Laboratories AB. deviCERTS medical device catalogue. https://devicerts.com/devices/raystation-version-1-0-muj (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/raystation-version-1-0-muj",
    "json_url": "https://devicerts.com/devices/raystation-version-1-0-muj.json",
    "markdown_url": "https://devicerts.com/devices/raystation-version-1-0-muj.md",
    "publisher": "deviCERTS (devicerts.com)",
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    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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-version-1-0-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 Version 1.0",
    "registry_name": "RAYSTATION VERSION 1.0",
    "url": "https://devicerts.com/devices/raystation-version-1-0-muj",
    "manufacturer": {
      "name": "Raysearch Laboratories AB",
      "url": "https://devicerts.com/manufacturers/raysearch-laboratories-ab",
      "country": "Sweden",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
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      "MUJ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
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      "number_label": null,
      "device_udi_di": null,
      "date": "2010-03-12",
      "date_kind": "decision",
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      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1481-2014",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-02-14",
      "reason": "RaySearch Laboratories has recalled \"RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0\" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.",
      "applies": "this device",
      "via": "K100552"
    },
    {
      "number": "Z-1307-2014",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-02-06",
      "reason": "Potential for dose errors due to software program errors.",
      "applies": "this device",
      "via": "K100552"
    },
    {
      "number": "Z-1317-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2011-12-06",
      "reason": "An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose.  This could lead to the potential under-dosage of a patient.",
      "applies": "this device",
      "via": "K100552"
    },
    {
      "number": "Z-0359-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2011-10-19",
      "reason": "The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual.  The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.",
      "applies": "this device",
      "via": "K100552"
    }
  ],
  "eu_market_availability": null,
  "properties": [
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.5050",
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        },
        {
          "label": "Advisory committee",
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}