{
  "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": "2026-09-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Munich",
      "advisory_committee_description": "Radiology",
      "address_1": "Olof-Palme-Str 9",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MUJ",
      "openfda": {
        "registration_number": [
          "3025765259",
          "3004977335",
          "9611894",
          "1651102",
          "3007774465",
          "3013410552",
          "3010123525",
          "3022719374",
          "3019834893",
          "3044735888",
          "3003586672",
          "3011716550",
          "3005136058",
          "3007037519",
          "3003094912",
          "3014873236",
          "3033527281",
          "3004555507",
          "3006894636",
          "9617978",
          "3009090417",
          "2183553",
          "2434141",
          "3016602874",
          "3009077524",
          "3004580128",
          "3042177665",
          "2030598",
          "3008156050",
          "3004363352",
          "3007791541",
          "3009529630",
          "3014425747",
          "3002808157",
          "3004608878",
          "3015777306",
          "3016686005",
          "3019543601",
          "3012039133",
          "3004561814",
          "3003793371",
          "3010034862",
          "3000126629",
          "2939248",
          "3009302839",
          "3022745617",
          "3003873069",
          "3004526608",
          "3006579682",
          "3003768277",
          "3003418325",
          "3023344262",
          "3015232217",
          "3030564015",
          "8043933",
          "2916710",
          "1038814",
          "3018004899"
        ],
        "fei_number": [
          "3008581796",
          "3025765259",
          "3004977335",
          "3007774465",
          "3013410552",
          "3010123525",
          "3022719374",
          "3019834893",
          "3044735888",
          "3003586672",
          "3011716550",
          "3005136058",
          "3007037519",
          "3003094912",
          "3014873236",
          "3033527281",
          "3004555507",
          "3006894636",
          "3002807880",
          "3009090417",
          "3002802883",
          "2183553",
          "2434141",
          "3016602874",
          "3002807741",
          "3009077524",
          "3042177665",
          "3004580128",
          "3008156050",
          "3004363352",
          "3007791541",
          "3009529630",
          "1000518731",
          "3014425747",
          "3002808157",
          "3004608878",
          "3015777306",
          "3016686005",
          "3019543601",
          "3012039133",
          "3004561814",
          "3003793371",
          "3010034862",
          "3000126629",
          "2939248",
          "3009302839",
          "3022745617",
          "3003873069",
          "3004526608",
          "3006579682",
          "3023344262",
          "3003418325",
          "3002619595",
          "3015232217",
          "3030564015",
          "2916710",
          "1038814",
          "3018004899"
        ],
        "device_name": "System, Planning, Radiation Therapy Treatment",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      },
      "zip_code": "81829",
      "applicant": "Brainlab AG",
      "decision_date": "2025-06-17",
      "decision_code": "SESE",
      "country_code": "DE",
      "device_name": "RT Elements  (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT",
      "advisory_committee": "RA",
      "contact": "Sadwini  Suresh",
      "expedited_review_flag": "",
      "k_number": "K250440",
      "state": "",
      "date_received": "2025-02-14",
      "review_advisory_committee": "RA",
      "postal_code": "81829",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}