{
  "format": "devicerts.device.v1",
  "cite_as": "Modeification to Iplan Rt Dose, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj",
    "json_url": "https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj.json",
    "markdown_url": "https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/modeification-to-iplan-rt-dose-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": "Modeification to Iplan Rt Dose",
    "registry_name": "MODEIFICATION TO IPLAN RT DOSE",
    "url": "https://devicerts.com/devices/modeification-to-iplan-rt-dose-muj",
    "manufacturer": {
      "name": "Brainlab AG",
      "url": "https://devicerts.com/manufacturers/brainlab-ag",
      "country": null,
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K080888",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MUJ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K080888",
      "number_label": null,
      "device_udi_di": null,
      "date": "2008-06-11",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0957-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-11-19",
      "reason": "iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.",
      "applies": "this device",
      "via": "K080888"
    },
    {
      "number": "Z-0956-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-11-19",
      "reason": "iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.",
      "applies": "this device",
      "via": "K080888"
    },
    {
      "number": "Z-2251-2009",
      "classification": "",
      "status": "terminated",
      "initiated": "2009-08-12",
      "reason": "Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.",
      "applies": "this device",
      "via": "K080888"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K080888",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "MUJ",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.5050",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}