{
  "format": "devicerts.device.v1",
  "cite_as": "AVIEW, Coreline Soft Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/aview-cls-usr-003-eu (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/aview-cls-usr-003-eu",
    "json_url": "https://devicerts.com/devices/aview-cls-usr-003-eu.json",
    "markdown_url": "https://devicerts.com/devices/aview-cls-usr-003-eu.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": "2026-10-23",
    "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/aview-cls-usr-003-eu",
    "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": "AVIEW",
    "registry_name": "AVIEW",
    "url": "https://devicerts.com/devices/aview-cls-usr-003-eu",
    "manufacturer": {
      "name": "Coreline Soft Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3015169361",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDR"
      },
      {
        "class": "Class IIa",
        "system": "EU MDR"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08800025300114",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "88000253A001B2",
            "registries": [
              "EUDAMED"
            ]
          },
          {
            "value": "B-08800025300114",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      }
    ],
    "product_codes": [],
    "emdn": [
      {
        "code": "Z11069092",
        "term": "VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE"
      },
      {
        "code": "Z110603",
        "term": "PICTURE ARCHIVING AND COMMUNICATION SYSTEMS"
      }
    ],
    "gmdn": [],
    "description": {
      "text": "AVIEW is a Class IIb medical imaging device designed for diagnostic use in radiology. The device is manufactured by Coreline Soft Co., Ltd. and is not sterile, implantable, or reusable.\n\nThe AVIEW device is supplied as a standard medical device and is not intended for administering medicine or containing animal or human tissues. It is authorized under FDA 510K, MDD, and MDR regulations, with a reference number of CLS-USR-003(EU). The device is active and has a basic UDI of 88000253A001B2.",
      "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": "K243689",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-03-19",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "88000253A001B2",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08800025300114",
      "date": "2024-11-18",
      "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": "K214036",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-12-23",
      "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": "K200714",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-08-26",
      "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": "K171199",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-10-31",
      "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": "Model / reference",
          "values": [
            {
              "value": "CLS-USR-003(EU)",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "CLS-2021-001",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "08800025300114",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "88000253A001B2",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "B-08800025300114",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Z11069092",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Z110603",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIb",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Class IIa",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Special device type",
          "values": [
            {
              "value": "Software",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Legacy device (under a directive)",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Germany",
              "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"
              ]
            }
          ]
        }
      ]
    }
  ]
}