{
  "format": "devicerts.device.v1",
  "cite_as": "ART.1-US, SeeTreat Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/art-1-us-muj (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/art-1-us-muj.json",
    "markdown_url": "https://devicerts.com/devices/art-1-us-muj.md",
    "publisher": "deviCERTS (devicerts.com)",
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      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "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/art-1-us-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": "ART.1-US",
    "registry_name": "ART.1-US",
    "url": "https://devicerts.com/devices/art-1-us-muj",
    "manufacturer": {
      "name": "SeeTreat Pty Ltd",
      "url": "https://devicerts.com/manufacturers/seetreat-pty-ltd",
      "country": "Australia",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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        "system": "US FDA"
      }
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        "values": [
          {
            "value": "K253078",
            "registries": [
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        ]
      }
    ],
    "product_codes": [
      "MUJ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The ART.1-US is a System, Planning, Radiation Therapy Treatment, designed for radiation oncology planning and treatment. It provides advanced computational tools to optimize radiation dose delivery, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissue. This system integrates with existing workflows to enhance treatment accuracy and efficiency in radiotherapy.\n\nSupplied as a software solution, the ART.1-US is intended for use in clinical settings by qualified radiation oncologists and treatment planners. It operates as a standalone system without requiring additional hardware, making it adaptable to existing infrastructure. The device is classified under FDA 510(k) clearance and MDR, adhering to regulatory standards for radiation therapy planning systems. No specific sterility or single-use requirements are noted, as it is a reusable software-based tool.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K253078",
      "number_label": null,
      "device_udi_di": null,
      "date": "2026-05-14",
      "date_kind": "decision",
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      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
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    }
  ],
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  "certificates": [],
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  "properties": [
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.5050",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
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            }
          ]
        },
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}