{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SEZ",
      "openfda": {
        "k_number": [
          "DEN240047"
        ],
        "registration_number": [
          "3042248140"
        ],
        "fei_number": [
          "3042248140"
        ]
      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "Radiological Software Device To Predict Future Breast Cancer Risk",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams.",
      "regulation_number": "892.8500",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}