{
  "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": "SHE",
      "openfda": {
        "k_number": [
          "DEN250007"
        ],
        "registration_number": [
          "3044467584"
        ],
        "fei_number": [
          "3044467584"
        ]
      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "Radiological Software System For Delivery Date Prediction",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications.",
      "regulation_number": "892.8200",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}