{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Synapse Pathology Software"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3008491142",
        "fei_number": "3008491142",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "FUJIFILM Healthcare Americas Corporation",
        "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": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "FUJIFILM Healthcare Americas Corporation",
          "owner_operator_number": "10043450",
          "official_correspondent": {
            "first_name": "Randy",
            "middle_initial": "",
            "last_name": "Vader",
            "subaccount_company_name": "",
            "phone_number": "x-360-3566821-x"
          },
          "contact_address": {
            "address_1": "81 Hartwell Avenue, Suite 100",
            "address_2": "",
            "city": "Lexington",
            "state_code": "MA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "02421"
          }
        }
      },
      "pma_number": "",
      "k_number": "K210811",
      "products": [
        {
          "product_code": "PSY",
          "created_date": "2022-06-01",
          "owner_operator_number": "10043450",
          "exempt": "",
          "openfda": {
            "device_name": "Whole Slide Imaging System",
            "medical_specialty_description": "Pathology",
            "regulation_number": "864.3700",
            "device_class": "2"
          }
        },
        {
          "product_code": "QKQ",
          "created_date": "2022-06-01",
          "owner_operator_number": "10043450",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K210811"
            ],
            "device_name": "Digital Pathology Image Viewing And Management Software",
            "medical_specialty_description": "Pathology",
            "regulation_number": "864.3700",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}