{
  "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": 15
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Ortho Tool Kit",
        "IMPAX Orthopaedic Workstation"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9616389",
        "fei_number": "3009471886",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "AGFA HEALTHCARE N.V.",
        "address_line_1": "SEPTESTRAAT 27",
        "address_line_2": "",
        "city": "MORTSEL Antwerpen",
        "state_code": "",
        "iso_country_code": "BE",
        "zip_code": "",
        "postal_code": "B 2640",
        "us_agent": {
          "name": "Joanne Hassell",
          "business_name": "",
          "bus_phone_area_code": "551",
          "bus_phone_num": "5560553",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "joanne.hassell@agfa.com",
          "address_line_1": "762 4th St",
          "address_line_2": "",
          "city": "Secaucus",
          "state_code": "NJ",
          "iso_country_code": "US",
          "zip_code": "07094",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "AGFA HEALTHCARE N.V.",
          "owner_operator_number": "9011611",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "375 Hagey Blvd",
            "address_2": "",
            "city": "Waterloo",
            "state_code": "CA-ON",
            "state_province": "Ontario",
            "iso_country_code": "CA",
            "postal_code": "N2L 6R5"
          }
        }
      },
      "pma_number": "",
      "k_number": "K071972",
      "products": [
        {
          "product_code": "LLZ",
          "created_date": "2008-01-16",
          "owner_operator_number": "9011611",
          "exempt": "",
          "openfda": {
            "device_name": "System, Image Processing, Radiological",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2050",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}