{
  "format": "devicerts.device.v1",
  "cite_as": "Srt-100+, Sensus Healthcare, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/srt-100-jad (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/srt-100-jad",
    "json_url": "https://devicerts.com/devices/srt-100-jad.json",
    "markdown_url": "https://devicerts.com/devices/srt-100-jad.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-05",
    "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/srt-100-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": "Srt-100+",
    "registry_name": "SRT-100+",
    "url": "https://devicerts.com/devices/srt-100-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": "K173425",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "JAD"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The SRT-100+ is a Therapeutic X-Ray System designed for superficial radiotherapy, delivering targeted radiation to treat skin conditions. It is classified as a Class II medical device under FDA regulations, intended for non-invasive treatment of superficial lesions, including non-melanoma skin cancer and keloids. The system employs precise radiation delivery to minimize collateral damage to surrounding tissues while addressing pathological tissue at the treatment site.\n\nThis device is supplied as a reusable system, intended for use in clinical settings such as dermatology and oncology practices, as well as hospitals. It operates under sterile conditions during treatment application and requires proper calibration and maintenance per manufacturer guidelines. The SRT-100+ holds FDA 510(k) clearance (K173425) and adheres to regulatory standards outlined in 21 CFR 892.5900. No MRI compatibility or single-use components are specified in the regulatory data.",
      "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": "K173425",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-03-23",
      "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": "K173425",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "JAD",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "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)"
              ]
            }
          ]
        }
      ]
    }
  ]
}