{
  "format": "devicerts.device.v1",
  "cite_as": "Intuition Image, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/intuition-image-lhn (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/intuition-image-lhn",
    "json_url": "https://devicerts.com/devices/intuition-image-lhn.json",
    "markdown_url": "https://devicerts.com/devices/intuition-image-lhn.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "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/intuition-image-lhn",
    "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": "Intuition Image",
    "registry_name": "INTUITION IMAGE",
    "url": "https://devicerts.com/devices/intuition-image-lhn",
    "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": "K032511",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LHN"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Intuition Image is a Medical Charged-Particle Radiation Therapy System, designed for precise delivery of radiation therapy using charged particles. It integrates imaging and treatment planning capabilities to enhance accuracy in radiotherapy for cancer treatment, aligning with FDA-recognized standards for radiation therapy devices. This system falls under the classification of a System, Radiation Therapy, Charged-Particle, Medical device, ensuring compliance with regulatory requirements for high-risk medical applications.\n\nThe Intuition Image is supplied as a Class II medical device, regulated under 21 CFR 892.5050 and cleared via FDA 510(k) submission (K032511). It is intended for use in radiology settings, where its advanced imaging and treatment planning functionalities support targeted radiation therapy. The device is not described as single-use or reusable in the regulatory data, though its design suggests it is intended for institutional use in controlled environments. No specific sterility or MRI safety information is provided in the available documentation.",
      "ai_generated": true,
      "generated_on": "2026-09-20",
      "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": "K032511",
      "number_label": null,
      "device_udi_di": null,
      "date": "2004-01-21",
      "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": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K032511",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LHN",
              "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)"
              ]
            }
          ]
        }
      ]
    }
  ]
}