{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "; GE Revolution CT, Siemens SOMATOM Definition Flash, Philips Ingenuity CT",
        "Canon Aquilion Prime ; Hologic Horizon DXA, GE Lunar iDXA GE Healthcare  Optima XR646, Discovery XR656",
        "Hologic Selenia Dimensions, GE Senographe Pristina, Siemens MAMMOMAT Revelation, Fujifilm Amulet Innovality ;",
        "Radrex-i, Ultimax-i (fluoroscopy + X-ray) ; GE Voluson E10, Philips EPIQ 7, Siemens ACUSON Sequoia, Canon Aplio i700",
        "Siemens Healthineers  Ysio Max, Multix Impact ; Philips Healthcare  DigitalDiagnost C90, ProGrade, Canon Medical"
      ],
      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3040678329",
        "fei_number": "3040678329",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "PRIMEX MEDICAL PTY LTD",
        "address_line_1": "56 Daglish St",
        "address_line_2": "",
        "city": "Wembley Western Australia",
        "state_code": "",
        "iso_country_code": "AU",
        "zip_code": "",
        "postal_code": "6014",
        "us_agent": {
          "name": "David Lennarz",
          "business_name": "Registrar Corp",
          "bus_phone_area_code": "757",
          "bus_phone_num": "2240177",
          "bus_phone_extn": "",
          "fax_area_code": "757",
          "fax_num": "2240179",
          "email_address": "David.Lennarz@registrarcorp.com",
          "address_line_1": "144 Research Drive",
          "address_line_2": "",
          "city": "Hampton",
          "state_code": "VA",
          "iso_country_code": "US",
          "zip_code": "23666",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "PrimeX Medical Pty Ltd",
          "owner_operator_number": "10094145",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "56 Daglish St",
            "address_2": "",
            "city": "Wembley",
            "state_code": "AU-WA",
            "state_province": "Western Australia",
            "iso_country_code": "AU",
            "postal_code": "6014"
          }
        }
      },
      "pma_number": "P080003",
      "k_number": "",
      "products": [
        {
          "product_code": "OTE",
          "created_date": "2025-11-17",
          "owner_operator_number": "10094145",
          "exempt": "",
          "openfda": {
            "pma_number": [
              "P080003"
            ],
            "device_name": "Digital Breast Tomosynthesis",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ]
    }
  ]
}