{
  "format": "devicerts.device.v1",
  "cite_as": "GenIQ, GE Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/geniq-llz (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/geniq-llz",
    "json_url": "https://devicerts.com/devices/geniq-llz.json",
    "markdown_url": "https://devicerts.com/devices/geniq-llz.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": "2026-11-14",
    "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/geniq-llz",
    "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": "GenIQ",
    "registry_name": "GenIQ",
    "url": "https://devicerts.com/devices/geniq-llz",
    "manufacturer": {
      "name": "GE Medical Systems, Inc.",
      "url": "https://devicerts.com/manufacturers/ge-medical-systems-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K143368",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "GenIQ is a medical device manufactured by GE Medical Systems, LLC. It is identified under FDA 510(k) clearance K143368.\n\nThis device is subject to FDA 510(k) premarket notification requirements. It is categorized under the radiology advisory committee and product code LLZ.",
      "ai_generated": true,
      "generated_on": "2026-09-22",
      "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": "K143368",
      "number_label": null,
      "device_udi_di": null,
      "date": "2015-07-29",
      "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": "K143368",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LLZ",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
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            }
          ]
        },
        {
          "label": "FDA decision",
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            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}