{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 47
    }
  },
  "results": [
    {
      "proprietary_name": [
        "EW10-EC02"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3001722928",
        "fei_number": "3001722928",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "FUJIFILM CORPORATION",
        "address_line_1": "798 MIYANODAI KAISEI-MACHI",
        "address_line_2": "",
        "city": "ASHIGARAKAMI-GUN Kanagawa",
        "state_code": "",
        "iso_country_code": "JP",
        "zip_code": "",
        "postal_code": "258-8538",
        "us_agent": {
          "name": "Randy Vader",
          "business_name": "FUJIFILM Healthcare Americas Corporation",
          "bus_phone_area_code": "360",
          "bus_phone_num": "3566821",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "randy.vader@fujifilm.com",
          "address_line_1": "81 Hartwell Ave Ste 100",
          "address_line_2": "",
          "city": "Lexington",
          "state_code": "MA",
          "iso_country_code": "US",
          "zip_code": "02421",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "FUJIFILM CORPORATION",
          "owner_operator_number": "8031568",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "26-30, Nishiazabu 2-chome",
            "address_2": "",
            "city": "MINATO-KU",
            "state_code": "JP-13",
            "state_province": "Tokyo",
            "iso_country_code": "JP",
            "postal_code": "106-8620"
          }
        }
      },
      "pma_number": "",
      "k_number": "K260567",
      "products": [
        {
          "product_code": "QNP",
          "created_date": "2026-08-28",
          "owner_operator_number": "8031568",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K260567"
            ],
            "device_name": "Gastrointesinal Lesion Software Detection System",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1520",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}