{
  "format": "devicerts.device.v1",
  "cite_as": "Sensus IORT System, Sensus Healthcare, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sensus-iort-system-jad (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/sensus-iort-system-jad",
    "json_url": "https://devicerts.com/devices/sensus-iort-system-jad.json",
    "markdown_url": "https://devicerts.com/devices/sensus-iort-system-jad.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "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/sensus-iort-system-jad",
    "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": "Sensus IORT System",
    "registry_name": "Sensus IORT System",
    "url": "https://devicerts.com/devices/sensus-iort-system-jad",
    "manufacturer": {
      "name": "Sensus Healthcare, Inc.",
      "url": "https://devicerts.com/manufacturers/sensus-healthcare",
      "country": "United States",
      "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": "K182641",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JAD"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Sensus IORT System is a therapeutic X-ray device designed for intraoperative radiotherapy (IORT), delivering precise radiation doses directly to tumor sites during surgery. Classified as a Class II medical device, it is intended for use in radiology settings to provide targeted radiation therapy while minimizing exposure to surrounding healthy tissue. The system leverages intraoperative delivery to enhance localized control of cancerous growths, particularly in complex or high-risk cases where traditional external beam radiotherapy may be less effective. Its design aligns with radiology-based interventions, ensuring integration with surgical workflows for optimal clinical outcomes.\n\nThe Sensus IORT System is supplied as a reusable medical device, with components and accessories intended for single-use or as specified by the manufacturer. It is not MRI-compatible and must be used in environments compliant with radiation safety protocols. The system includes multiple reference codes (e.g., 3009732568, 3023344262) and is regulated under FDA 510(k) clearance (K182641) as a substantially equivalent device to a predicate, falling under regulation number 892.5900. Storage and handling follow manufacturer guidelines to maintain sterility and functionality, ensuring safe intraoperative use in radiology departments.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K182641",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-02-21",
      "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": "K182641",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "JAD",
              "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 892.5900",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}