{
  "format": "devicerts.device.v1",
  "cite_as": "ADAS3D, ADAS3D Medical, S.L. deviCERTS medical device catalogue. https://devicerts.com/devices/adas3d-adas-3d (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/adas3d-adas-3d",
    "json_url": "https://devicerts.com/devices/adas3d-adas-3d.json",
    "markdown_url": "https://devicerts.com/devices/adas3d-adas-3d.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/adas3d-adas-3d",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "ADAS3D",
    "registry_name": "ADAS3D",
    "url": "https://devicerts.com/devices/adas3d-adas-3d",
    "manufacturer": {
      "name": "ADAS3D Medical, S.L.",
      "url": "https://devicerts.com/manufacturers/adas3d-medical-s-l",
      "country": "Spain",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIa",
        "system": "EU MDR / EU MDD"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08437021722017",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "B-08437021722017",
            "registries": [
              "EUDAMED"
            ]
          },
          {
            "value": "8437021722ADAS3DWX",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [
      {
        "code": "Z11039082",
        "term": "VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES"
      },
      {
        "code": "Z12059092",
        "term": "VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - MEDICAL DEVICE SOFTWARE"
      }
    ],
    "gmdn": [],
    "description": {
      "text": "The ADAS3D is a Class IIa active medical device, classified under nomenclature code Z11039082. It is designed as a diagnostic imaging system, specifically for three-dimensional (3D) imaging of anatomical structures, enabling detailed visualization for clinical assessment.\n\nThis device is non-sterile, non-reusable, and non-implantable, intended for single-use applications. Supplied with a unique Basic UDI (B-08437021722017), it operates in clinical settings such as radiology departments and is authorized under FDA 510K, MDD, and MDR regulations. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K240791",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-09-09",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K230803",
      "number_label": null,
      "device_udi_di": null,
      "date": "2023-05-23",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "B-08437021722017",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08437021722017",
      "date": "2021-10-05",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": "B-08437021722017",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08437021722017",
      "date": "2021-10-05",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K212421",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-09-03",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K210850",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-04-05",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Device name",
          "values": [
            {
              "value": "ADAS3D",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "ADAS 3D",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "ADAS 3D",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "ADAS 3D ver. 2.9",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "08437021722017",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "B-08437021722017",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "8437021722ADAS3DWX",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Z11039082",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Z12059092",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIa",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Special device type",
          "values": [
            {
              "value": "Software",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Legacy device (under a directive)",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Spain",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    }
  ]
}