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Interventional Angiography System Infx-8000F

by Canon Inc.

Ref INFX-8000FModel INFX-8000C, INFX-8000F, etc.

Interventional Angiography System Infx-8000F is a stationary angiographic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code MQB, Solid state x-ray imager (flat panel/digital imager)) made by Canon Inc., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 4987670A0101QY), cleared under FDA 510(k) K182415 on 28 Sep 2018 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 04987670100208), active as of 22 Oct 2026. 7 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182415

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4987670A0101QY Basic UDI-DI 04987670100208UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182415 Date28 Sep 2018DecidedStatusActive
United StatesGUDID listing GUDID Number04987670100208 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4987670A0101QY registered 15 Jun 2026 Active
  • FDA 510(k) K182415 decided 28 Sep 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04987670100208 listed 1 Sep 2016 Listed

Recalls

13 recalls · 8 ongoing · FDA

    • Ongoing Z-0290-2027 FDA Not yet classified initiated 12 Oct 2026 on shared 510(k) K182415

    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.

    • Ongoing Z-3014-2026 FDA Class II initiated 4 Aug 2026 on shared 510(k) K182415

    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.

    • Ongoing Z-1177-2026 FDA Class II initiated 19 Dec 2025 on shared 510(k) K182415

    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

    • Ongoing Z-1155-2024 FDA Class II initiated 15 Nov 2023 on shared 510(k) K182415

    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.

    • Ongoing Z-0492-2022 FDA Class II initiated 20 Dec 2021 on shared 510(k) K182415

    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.

    • Ongoing Z-1176-2021 FDA Class II initiated 5 Feb 2021

    The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

    • Ongoing Z-1271-2021 FDA Class II initiated 8 Dec 2020

    System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

    • Ongoing Z-2327-2020 FDA Class II initiated 3 Mar 2020

    Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

    • Terminated Z-0360-2020 FDA Class II initiated 8 Feb 2019

    Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

    • Terminated Z-0842-2018 FDA Class II initiated 29 Dec 2017 on shared 510(k) K081624

    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.

    • Terminated Z-0994-2013 FDA Class II initiated 8 Nov 2012

    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.

    • Terminated Z-0331-2012 FDA Unclassified (pre-2012) initiated 3 Oct 2011

    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.

    • Terminated Z-0005-2009 FDA Unclassified (pre-2012) initiated 29 Sep 2008

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

17 dated events

  1. Recall initiated FDA recalls Z-0360-2020
  2. Recall initiated FDA recalls Z-2327-2020
  3. Recall initiated FDA recalls Z-1271-2021
  4. Recall initiated FDA recalls Z-1176-2021
  5. Recall initiated FDA recalls Z-0492-2022
  6. Recall initiated FDA recalls Z-1155-2024
  7. Recall initiated FDA recalls Z-1177-2026
  8. Registered EUDAMED 4987670A0101QY
  9. Recall initiated FDA recalls Z-3014-2026
  10. Recall initiated FDA recalls Z-0290-2027

7 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Interventional Angiography System
Generic name
Stationary angiographic x-ray system, digital
Model / reference
INFX-8000F, INFX-8000C, etc.
Primary DI / UDI-DI
04987670100208
Basic UDI-DI
4987670A0101QY
510(k) Number
FDA product code
MQB
EMDN code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
GMDN term
Stationary angiographic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Stationary angiographic x-ray system, digital

Similar devices in this category

Other devices filed under STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES.

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Serial number
Other properties (24, all answered No)