{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SFH",
      "openfda": {
        "k_number": [
          "DEN240068"
        ],
        "registration_number": [
          "3029787717"
        ],
        "fei_number": [
          "3029787717"
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      },
      "review_panel": "PA",
      "medical_specialty": "PA",
      "device_name": "Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Pathology",
      "device_class": "2",
      "definition": "A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.",
      "regulation_number": "864.3755",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}