{
  "format": "devicerts.device.v1",
  "cite_as": "VirtuOst Bone Densitometer, O.N. Diagnostics. deviCERTS medical device catalogue. https://devicerts.com/devices/virtuost-kgi (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/virtuost-kgi",
    "json_url": "https://devicerts.com/devices/virtuost-kgi.json",
    "markdown_url": "https://devicerts.com/devices/virtuost-kgi.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/virtuost-kgi",
    "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": "VirtuOst Bone Densitometer",
    "registry_name": "VIRTUOST",
    "url": "https://devicerts.com/devices/virtuost-kgi",
    "manufacturer": {
      "name": "O.N. Diagnostics",
      "url": "https://devicerts.com/manufacturers/o-n-diagnostics",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K113725",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KGI"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The VirtuOst Bone Densitometer is a medical device classified as a bone densitometer, designed to estimate bone mineral density, bone strength, and load-to-strength ratios. It processes data from computed tomography (CT) scans to provide quantitative assessments of bone health, aiding in fracture risk assessment, osteoporosis identification, and therapeutic monitoring. This device leverages existing CT imaging to derive clinically relevant metrics without requiring additional scans, making it a non-invasive diagnostic tool for radiology applications.\n\nThe VirtuOst is supplied as a software-based solution integrated with CT imaging systems, intended for use in radiology settings. It is not classified as single-use or reusable but operates as a standalone analytical tool. The device adheres to FDA 510(k) clearance (K113725) under the Radiology advisory committee, with regulatory classification as a Class II device (892.1170). No specific sterility or MRI safety information is provided, and its use is restricted to qualified healthcare professionals for diagnostic interpretation.",
      "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": "K113725",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-09-13",
      "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": "K113725",
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            }
          ]
        },
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    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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                "FDA 510(k)"
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.1170",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
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            }
          ]
        },
        {
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            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}