Canon Inc., Digital Radiography, Model CXDI-40C

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K031633 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Canon USA, Inc. →

• What is the Canon CXDI-40C used for?

  The Canon CXDI-40C is a solid state X-ray imager designed for digital radiography. It provides digital image capture for conventional film/screen radiographic examinations and is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

• Is the Canon CXDI-40C a single-use or reusable device?

  The Canon CXDI-40C is supplied as a reusable system. It is designed for repeated use in clinical settings for digital radiography procedures, rather than being a disposable single-use device.

• What is the regulatory status of the Canon CXDI-40C?

  The Canon CXDI-40C is authorized under FDA 510K clearance with product code MQB and regulation number 892.1680. It is classified as a Class II medical device for radiology applications, manufactured by Canon USA, Inc.

• Is the Canon CXDI-40C compatible with MRI procedures?

  The Canon CXDI-40C is not specified as MRI compatible. It is designed specifically for digital radiography applications and should not be used in MRI environments unless specifically validated for such use.