{
  "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": "QWT",
      "openfda": {
        "k_number": [
          "DEN220066"
        ],
        "registration_number": [
          "3030624673"
        ],
        "fei_number": [
          "3030624673"
        ]
      },
      "review_panel": "NE",
      "medical_specialty": "NE",
      "device_name": "Prognostic Assessment Software Of Mild Cognitive Impairment",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Neurology",
      "device_class": "2",
      "definition": "Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too.",
      "regulation_number": "882.1454",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}