{
  "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": "QHA",
      "openfda": {
        "k_number": [
          "K182611",
          "K251355",
          "K243769",
          "K232147",
          "K230303",
          "K221711",
          "K210093"
        ],
        "registration_number": [
          "9614587",
          "9710122",
          "3038136528",
          "3017654247"
        ],
        "fei_number": [
          "3003595527",
          "3006974930",
          "3038136528",
          "3017654247"
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      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data.  X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.",
      "regulation_number": "892.1600",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}