{
  "format": "devicerts.device.v1",
  "cite_as": "Rayvolve PTX-PE, Azmed. deviCERTS medical device catalogue. https://devicerts.com/devices/rayvolve-ptx-pe-qfm (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/rayvolve-ptx-pe-qfm.json",
    "markdown_url": "https://devicerts.com/devices/rayvolve-ptx-pe-qfm.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "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/rayvolve-ptx-pe-qfm",
    "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": "Rayvolve PTX-PE",
    "registry_name": "Rayvolve PTX-PE",
    "url": "https://devicerts.com/devices/rayvolve-ptx-pe-qfm",
    "manufacturer": {
      "name": "Azmed",
      "url": "https://devicerts.com/manufacturers/azmed",
      "country": "France",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "European Union and United States"
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        "system": "US FDA"
      }
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            "value": "K243808",
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        ]
      }
    ],
    "product_codes": [
      "QFM"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Rayvolve PTX-PE is a Radiological Computer-Assisted Prioritization Software for Lesions, designed to assist radiologists in evaluating and prioritising pulmonary nodules and other lesions within chest imaging studies. This Class II device leverages AI-driven algorithms to enhance diagnostic workflows by identifying and stratifying findings based on predefined risk criteria, thereby supporting more efficient and standardised assessments in radiology.\n\nSupplied as a software application, the Rayvolve PTX-PE operates within a clinical radiology setting and is intended for single-use per imaging session, though its software licence may allow repeated use across multiple studies. Authorised under FDA 510(k) and MDR, it adheres to regulatory standards for medical imaging software, with no specific sterility or reusable components. The device is non-invasive, MRI-safe, and does not require physical storage beyond the facility’s IT infrastructure. Its registration numbers include multiple FEI identifiers (e.g., 3034205378) under the QFM product code, reflecting its classification as a diagnostic imaging aid.",
      "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",
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      "device_udi_di": null,
      "date": "2025-03-21",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "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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      "decision_code": null,
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    }
  ],
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  "eu_market_availability": null,
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        {
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            {
              "value": "QFM",
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    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2080",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
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}