{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NWE",
      "openfda": {
        "k_number": [
          "K140920",
          "K042605",
          "K042674",
          "K083423"
        ],
        "registration_number": [
          "3004977335"
        ],
        "fei_number": [
          "3004977335"
        ]
      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "Colon Computed Tomography System, Computer Aided Detection",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.",
      "regulation_number": "892.2050",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}