{
  "format": "devicerts.device.v1",
  "cite_as": "Interventional Angiography System Infx-8000F, Canon Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/interventional-angiography-system-infx-8000f (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/interventional-angiography-system-infx-8000f",
    "json_url": "https://devicerts.com/devices/interventional-angiography-system-infx-8000f.json",
    "markdown_url": "https://devicerts.com/devices/interventional-angiography-system-infx-8000f.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
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      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/interventional-angiography-system-infx-8000f",
    "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": "Interventional Angiography System Infx-8000F",
    "registry_name": "INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000F",
    "url": "https://devicerts.com/devices/interventional-angiography-system-infx-8000f",
    "manufacturer": {
      "name": "Canon Inc.",
      "url": "https://devicerts.com/manufacturers/canon-inc",
      "country": "Japan",
      "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 II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "04987670100208",
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              "FDA GUDID (AccessGUDID)"
            ]
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      },
      {
        "label": "Basic UDI-DI",
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          {
            "value": "4987670A0101QY",
            "registries": [
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      {
        "label": "510(k) Number",
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          },
          {
            "value": "K182415",
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              "FDA GUDID (AccessGUDID)"
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          }
        ]
      }
    ],
    "product_codes": [
      "MQB",
      "OWB"
    ],
    "emdn": [
      {
        "code": "Z11030102",
        "term": "STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES"
      }
    ],
    "gmdn": [
      {
        "code": "37623",
        "term": "Stationary angiographic x-ray system, digital"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "4987670A0101QY",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "04987670100208",
      "date": "2026-06-15",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
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      "date": "2018-09-28",
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      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
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      "type": "GUDID listing",
      "number": "04987670100208",
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      "date": "2016-09-01",
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      "withdrawn": null,
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      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K081624",
      "number_label": null,
      "device_udi_di": null,
      "date": "2008-06-23",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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    {
      "number": "Z-0290-2027",
      "classification": "",
      "status": "ongoing",
      "initiated": "2026-10-12",
      "reason": "Due to software issue, X-ray interventional  system  may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.",
      "applies": "shared submission",
      "via": "K182415"
    },
    {
      "number": "Z-3014-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-08-04",
      "reason": "Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.",
      "applies": "shared submission",
      "via": "K182415"
    },
    {
      "number": "Z-1177-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2025-12-19",
      "reason": "It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional \nsystems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed",
      "applies": "shared submission",
      "via": "K182415"
    },
    {
      "number": "Z-1155-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-11-15",
      "reason": "VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.",
      "applies": "shared submission",
      "via": "K182415"
    },
    {
      "number": "Z-0492-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-12-20",
      "reason": "Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.",
      "applies": "shared submission",
      "via": "K182415"
    },
    {
      "number": "Z-1176-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-05",
      "reason": "The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-1271-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2020-12-08",
      "reason": "System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-2327-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2020-03-03",
      "reason": "Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-0360-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-02-08",
      "reason": "Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-0842-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-12-29",
      "reason": "During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.",
      "applies": "shared submission",
      "via": "K081624"
    },
    {
      "number": "Z-0994-2013",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2012-11-08",
      "reason": "Lost and incorrect images. When using the \"F-Rec\" fluoroscopy image acquisition recording option in the \"manual mode\" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-0331-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2011-10-03",
      "reason": "The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop.  The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.",
      "applies": "this device",
      "via": "K081624"
    },
    {
      "number": "Z-0005-2009",
      "classification": "",
      "status": "terminated",
      "initiated": "2008-09-29",
      "reason": "Audible signal is not available at all times when using the HLC fluoroscopy mode.  Special means of activation are not designed in for selection of High Level Controls, as required by regulation.",
      "applies": "this device",
      "via": "K081624"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
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        {
          "label": "Trade name",
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              "value": "INTERVENTIONAL ANGIOGRAPHY SYSTEM",
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            }
          ]
        },
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              ]
            }
          ]
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            {
              "value": "etc.",
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              "value": "Stationary angiographic x-ray system, digital",
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        {
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        {
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    {
      "group": "Properties",
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          "label": "Serial number",
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              "value": "Yes",
              "registries": [
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        },
        {
          "label": "Supplied sterile",
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        {
          "label": "Implantable",
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        {
          "label": "Contains latex",
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              "registries": [
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            }
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        {
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        {
          "label": "Lot / batch number",
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              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Expiration date",
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              "registries": [
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        {
          "label": "Manufacturing date",
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              "registries": [
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            }
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}