{
  "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": "Ineligible",
      "product_code": "QBS",
      "openfda": {
        "k_number": [
          "K193417",
          "K223491",
          "K240845",
          "K212365",
          "K242171",
          "K240712",
          "K220164",
          "K222176",
          "DEN180005"
        ],
        "registration_number": [
          "3026753394",
          "3013427569",
          "3007734888",
          "9616047",
          "3027453703",
          "2126677",
          "3014661828",
          "3021907554"
        ],
        "fei_number": [
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          "3003377038",
          "2126677",
          "3014661828",
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        ]
      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "Radiological Computer Assisted Detection/Diagnosis Software For Fracture",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.",
      "regulation_number": "892.2090",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}