{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "The Horizon® Dual-Energy X-Ray Absorptiometry (DXA) System is a computer-assisted\nX-Ray scanner used to aid a physician in measuring bone mineral density (BMD),\ndetermining fracture risk, and estimating the lean body mass and fat mass of non-osseous\ntissues.",
      "public_device_record_key": "fbf22201-2f22-4210-aa87-027a08ae394c",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "90"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        }
      ],
      "public_version_date": "2024-04-19",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "8",
      "labeler_duns_number": "153623137",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "15420045505827",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "Horizon Ci",
      "has_manufacturing_date": "true",
      "brand_name": "Horizon Ci",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "KGI",
          "name": "Densitometer, bone",
          "openfda": {
            "device_name": "Densitometer, Bone",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1170",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K023398",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "+1(800)442-9892",
          "email": "CustomerSupport@hologic.com"
        }
      ],
      "catalog_number": "Horizon-Ci",
      "company_name": "Hologic, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "37661",
          "name": "Bone absorptiometric x-ray system, dual-energy",
          "definition": "An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-08-23"
    }
  ]
}