{
  "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": "QKB",
      "openfda": {
        "k_number": [
          "K223774",
          "K230082",
          "K252548",
          "K241490",
          "K212218",
          "K242925",
          "K253270",
          "K181572",
          "K210632",
          "K250035",
          "K203610",
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          "K220813",
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          "K260509",
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          "3015232217",
          "3007120336",
          "3021982861",
          "3002808157",
          "3021032044",
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        "fei_number": [
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      "device_name": "Radiological Image Processing Software For Radiation Therapy",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images  typically impact device performance. AI based radiological image processing software  is intended to be used in the workflow of radiation therapy.  Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.",
      "regulation_number": "892.2050",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}