# Interventional Angiography System Infx-8000F > Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Canon Inc.](https://devicerts.com/manufacturers/canon-inc) (Japan) - Name in the registry: INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000F - Device class: Class IIb (EU MDR); Class II (US FDA) - FDA product code: MQB, OWB - EMDN: Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES - GMDN: Stationary angiographic x-ray system, digital (37623) ## Registrations and authorizations - **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 4987670A0101QY · UDI-DI 04987670100208 · registered 2026-06-15 · status: Active - **GUDID** · FDA 510(k) · United States · K182415 · decision 2018-09-28 · decision SESE · status: Active · from GUDID - **GUDID** · GUDID listing · United States · UDI-DI 04987670100208 · listed 2016-09-01 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA 510(k) · United States · K081624 · decision 2008-06-23 · decision SESE · status: Active · from GUDID ## Recalls - Z-0290-2027 · · ongoing · initiated 2026-10-12 · matched through shared submission K182415, may concern other models: 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. - Z-3014-2026 · Class II · ongoing · initiated 2026-08-04 · matched through shared submission K182415, may concern other models: 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. - Z-1177-2026 · Class II · ongoing · initiated 2025-12-19 · matched through shared submission K182415, may concern other models: 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 systems 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 - Z-1155-2024 · Class II · ongoing · initiated 2023-11-15 · matched through shared submission K182415, may concern other models: 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. - Z-0492-2022 · Class II · ongoing · initiated 2021-12-20 · matched through shared submission K182415, may concern other models: 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. - Z-1176-2021 · Class II · ongoing · initiated 2021-02-05: The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. - Z-1271-2021 · Class II · ongoing · initiated 2020-12-08: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. - Z-2327-2020 · Class II · ongoing · initiated 2020-03-03: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. - Z-0360-2020 · Class II · terminated · initiated 2019-02-08: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. - Z-0842-2018 · Class II · terminated · initiated 2017-12-29 · matched through shared submission K081624, may concern other models: 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. - Z-0994-2013 · Class II · terminated · initiated 2012-11-08: 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. - Z-0331-2012 · · terminated · initiated 2011-10-03: 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. - Z-0005-2009 · · terminated · initiated 2008-09-29: 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. ## Identity - Trade name: INTERVENTIONAL ANGIOGRAPHY SYSTEM [FDA GUDID (AccessGUDID)] - Generic name: Stationary angiographic x-ray system, digital [FDA GUDID (AccessGUDID)] - Model / reference: INFX-8000F [EUDAMED, FDA GUDID (AccessGUDID)]; INFX-8000C [EUDAMED]; etc. [EUDAMED] ## Identifiers - Primary DI / UDI-DI: 04987670100208 [EUDAMED, FDA GUDID (AccessGUDID)] - Basic UDI-DI: 4987670A0101QY [EUDAMED] - 510(k) Number: K081624 [FDA GUDID (AccessGUDID)]; K182415 [FDA GUDID (AccessGUDID)] - FDA product code: MQB [FDA GUDID (AccessGUDID)] - EMDN code: Z11030102 [EUDAMED] - GMDN term: Stationary angiographic x-ray system, digital (37623) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)] - Regulation number: 892.1680 [FDA GUDID (AccessGUDID)] - EU registration type: Standard device [EUDAMED] - EU market of registration: Netherlands [EUDAMED] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Properties - Serial number: Yes [FDA GUDID (AccessGUDID)] - Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)] - Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)] - Single use: No [FDA GUDID (AccessGUDID)] - Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)] - Reusable: No [EUDAMED] - Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)] - Reprocessed single-use device: No [EUDAMED] - Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED] - Incorporates a substance derived from human blood or plasma: No [EUDAMED] - Contains human tissues or cells: No [EUDAMED] - Contains animal tissues or cells: No [EUDAMED] - Contains endocrine-disrupting substances: No [EUDAMED] - Administering medicine: No [EUDAMED] - Measuring function: No [EUDAMED] - Incorporates a medicinal substance: No [EUDAMED] - Prescription use: No [FDA GUDID (AccessGUDID)] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - Convenience kit: No [FDA GUDID (AccessGUDID)] - Combination product: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Lot / batch number: No [FDA GUDID (AccessGUDID)] - Expiration date: No [FDA GUDID (AccessGUDID)] - Manufacturing date: No [FDA GUDID (AccessGUDID)] ## Source and citation - 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). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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 - 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.