{
  "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": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Optellum software",
        "Optellum platform",
        "Optellum Virtual Nodule Clinic"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "3015478020",
        "fei_number": "3015478020",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "OPTELLUM LTD",
        "address_line_1": "Five Kings Meadow",
        "address_line_2": "Osney Mead",
        "city": "Oxford Oxfordshire",
        "state_code": "",
        "iso_country_code": "GB",
        "zip_code": "",
        "postal_code": "OX2 0DP",
        "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": "Optellum Ltd",
          "owner_operator_number": "10060418",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Five Kings Meadow",
            "address_2": "Osney Mead",
            "city": "Oxford",
            "state_code": "GB-OXF",
            "state_province": "Oxfordshire",
            "iso_country_code": "GB",
            "postal_code": "OX2 0DP"
          }
        }
      },
      "pma_number": "",
      "k_number": "K202300",
      "products": [
        {
          "product_code": "POK",
          "created_date": "2021-03-31",
          "owner_operator_number": "10060418",
          "exempt": "",
          "openfda": {
            "device_name": "Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2060",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}