{
  "format": "devicerts.device.v1",
  "cite_as": "X-Guide Surgical Navigation System, X-Nav Technologies, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/x-guide-surgical-navigation-system-qry (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/x-guide-surgical-navigation-system-qry.json",
    "markdown_url": "https://devicerts.com/devices/x-guide-surgical-navigation-system-qry.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": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "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/x-guide-surgical-navigation-system-qry",
    "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": "X-Guide Surgical Navigation System",
    "registry_name": "X-Guide Surgical Navigation System",
    "url": "https://devicerts.com/devices/x-guide-surgical-navigation-system-qry",
    "manufacturer": {
      "name": "X-Nav Technologies, LLC",
      "url": "https://devicerts.com/manufacturers/x-nav-technologies-llc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
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    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K232148",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "QRY"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The X-Guide Surgical Navigation System is a Dental Navigation System, designed to assist in precise surgical planning and guidance for dental procedures. It integrates real-time imaging and tracking technologies to enhance accuracy during interventions such as implant placements or bone grafts, reducing operator reliance on manual measurements and improving procedural outcomes.\n\nThis system is supplied as a reusable medical device, intended for use in dental clinics and oral surgery settings. It operates in non-MRI environments and includes multiple registration numbers (3014552222, 3011874573, 3011764595, 3012787974) under FDA classification II (device class) and product code QRY. Authorized under FDA 510K clearance, MDD, and MDR compliance, it adheres to regulatory standards for dental surgical navigation.",
      "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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      "number": "K232148",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-02-21",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "status": "Active",
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    },
    {
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      "type": "CE/MDR",
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    {
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1393-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-03-04",
      "reason": "The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.",
      "applies": "this device",
      "via": "K232148"
    },
    {
      "number": "Z-1392-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-03-04",
      "reason": "The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.",
      "applies": "this device",
      "via": "K232148"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
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        {
          "label": "510(k) Number",
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          ]
        },
        {
          "label": "Advisory committee",
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            {
              "value": "Dental",
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          ]
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        {
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          ]
        }
      ]
    }
  ]
}