{
  "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": [
        "inHEART MODELS"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3018302800",
        "fei_number": "3018302800",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "INHEART",
        "address_line_1": "IHU Liryc - Hopital Xavier Arnozan",
        "address_line_2": "Avenue du Haut Leveque",
        "city": "Pessac Gironde",
        "state_code": "",
        "iso_country_code": "FR",
        "zip_code": "",
        "postal_code": "33600",
        "us_agent": {
          "name": "David Gareau",
          "business_name": "inHEART Inc",
          "bus_phone_area_code": "609",
          "bus_phone_num": "7131865",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "david.gareau@inheartmedical.com",
          "address_line_1": "4000 Eiland Drive",
          "address_line_2": "",
          "city": "Sebring",
          "state_code": "FL",
          "iso_country_code": "US",
          "zip_code": "33875",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "inHEART",
          "owner_operator_number": "10081210",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "IHU Liryc - Hopital Xavier Arnozan",
            "address_2": "Avenue du Haut Leveque",
            "city": "Pessac",
            "state_code": "FR-33",
            "state_province": "Gironde",
            "iso_country_code": "FR",
            "postal_code": "33600"
          }
        }
      },
      "pma_number": "",
      "k_number": "K231683",
      "products": [
        {
          "product_code": "QIH",
          "created_date": "2024-03-27",
          "owner_operator_number": "10081210",
          "exempt": "",
          "openfda": {
            "device_name": "Automated Radiological Image Processing Software",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2050",
            "device_class": "2"
          }
        },
        {
          "product_code": "LLZ",
          "created_date": "2024-03-27",
          "owner_operator_number": "10081210",
          "exempt": "",
          "openfda": {
            "device_name": "System, Image Processing, Radiological",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2050",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}