{
  "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": "QZS",
      "openfda": {
        "k_number": [
          "DEN230008"
        ],
        "registration_number": [
          "3017254114",
          "3016908271"
        ],
        "fei_number": [
          "3017254114",
          "3016908271"
        ]
      },
      "review_panel": "SU",
      "medical_specialty": "SU",
      "device_name": "Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General, Plastic Surgery",
      "device_class": "2",
      "definition": "A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion.  The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion.  It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.",
      "regulation_number": "878.1830",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}