{
  "format": "devicerts.device.v1",
  "cite_as": "LungVision Tool, Bodyvision Medical, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/lungvision-tool-eoq (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/lungvision-tool-eoq",
    "json_url": "https://devicerts.com/devices/lungvision-tool-eoq.json",
    "markdown_url": "https://devicerts.com/devices/lungvision-tool-eoq.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/lungvision-tool-eoq",
    "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": "LungVision Tool",
    "registry_name": "LungVision Tool",
    "url": "https://devicerts.com/devices/lungvision-tool-eoq",
    "manufacturer": {
      "name": "Bodyvision Medical, Ltd.",
      "url": "https://devicerts.com/manufacturers/bodyvision-medical-ltd",
      "country": "Israel",
      "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"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K172955",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EOQ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The LungVision Tool is a working channel device designed for use within the respiratory system. It serves as an interface to guide endotherapy accessories or ultrasound probes during bronchoscopic procedures, facilitating precise navigation to target areas in the lungs.\n\nThis device is intended for single-use and is compatible with standard bronchoscopes and Olympus Bronchoscope BF-1TH190. It is supplied sterile and is regulated under FDA 510K clearance (K172955) and MDR authorisation. The product code assigned is EOQ, categorised under the Ear, Nose, and Throat advisory committee classification.",
      "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."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K172955",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-04-26",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "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,
      "date_kind": null,
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
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      "fields": [
        {
          "label": "510(k) Number",
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            {
              "value": "K172955",
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            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "EOQ",
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            }
          ]
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      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.4680",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
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            {
              "value": "Ear, Nose, Throat",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA decision",
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            {
              "value": "SESE",
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            }
          ]
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}