{
  "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": "2026-08-31",
    "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": "SIU",
      "openfda": {
        "k_number": [
          "DEN250042"
        ],
        "registration_number": [
          "3017140520"
        ],
        "fei_number": [
          "3017140520"
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      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Predictive Indicator For Long-Term Cardiovascular Outcomes",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts  long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently  direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease.",
      "regulation_number": "870.2215",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}