{
  "format": "devicerts.device.v1",
  "cite_as": "BrainScan Radiosurgery Module, Brainlab. deviCERTS medical device catalogue. https://devicerts.com/devices/brainscan-radiosurgery-module-iye (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/brainscan-radiosurgery-module-iye",
    "json_url": "https://devicerts.com/devices/brainscan-radiosurgery-module-iye.json",
    "markdown_url": "https://devicerts.com/devices/brainscan-radiosurgery-module-iye.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": "2026-11-15",
    "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/brainscan-radiosurgery-module-iye",
    "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": "BrainScan Radiosurgery Module",
    "registry_name": "BRAINSCAN RADIOSURGERY MODULE",
    "url": "https://devicerts.com/devices/brainscan-radiosurgery-module-iye",
    "manufacturer": {
      "name": "Brainlab",
      "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": "K920879",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IYE"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The BrainScan Radiosurgery Module is a medical charged-particle radiation therapy system designed to accelerate high-energy charged particles (e.g., electrons and protons) for use in radiation therapy. It functions as a specialized component within a radiosurgery or radiotherapy treatment planning system, enabling precise targeting of lesions or tumors with focused radiation doses.\n\nThis module is intended for use in radiology settings and has been cleared by the FDA under the 510(k) pathway as substantially equivalent to prior devices. It is supplied as part of an integrated system and is not intended for standalone use. The device is classified under product code IYE and is regulated under 21 CFR 892.5050. No third-party review was required for this submission.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K920879",
      "number_label": null,
      "device_udi_di": null,
      "date": "1992-12-29",
      "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-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": "shared submission",
      "via": "K920879"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
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        {
          "label": "510(k) Number",
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            {
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            }
          ]
        },
        {
          "label": "FDA product code",
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              "value": "IYE",
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.5050",
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                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
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              "registries": [
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            }
          ]
        }
      ]
    }
  ]
}