{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 43
    }
  },
  "results": [
    {
      "pma_number": "P150038",
      "supplement_number": "S031",
      "applicant": "Insightec",
      "street_1": "5 Nahum Heth St.",
      "street_2": "",
      "city": "Tirat Carmel",
      "state": "",
      "zip": "39120",
      "zip_ext": "",
      "generic_name": "MR-guided focused ultrasound system",
      "trade_name": "Exablate Model 4000 System",
      "product_code": "POH",
      "advisory_committee": "NE",
      "advisory_committee_description": "Neurology",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2023-06-27",
      "decision_date": "2023-07-27",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Change to the Exablate Neuro manufacturing process to allow use of pre-owned systems and system components.",
      "openfda": {
        "registration_number": [
          "3008729892",
          "3012635238",
          "3005238200",
          "9615058"
        ],
        "fei_number": [
          "3003105983",
          "3002807555",
          "3005238200",
          "3012635238"
        ],
        "device_name": "Mr-Guided Focused Ultrasound System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}