Canon X-Ray Digital Camera CXDI-22

No FDA recalls on record, checked 22 Oct 2026.

Full name

Canon X-Ray Digital Camera, Model Cxdi-22

510(k) Number

K992547 ↗

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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• Canon X-Ray I.I. Rapid Sequence Camera Crs-105

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  FDA 510(k) K853861 Active Cleared 24 Oct 1985

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• Is the Canon X-Ray Digital Camera CXDI-22 designed for single-use or can it be reused in clinical settings?

  The Canon X-Ray Digital Camera CXDI-22 is explicitly described as a reusable medical instrument. Since it is intended for use in radiology settings and requires proper calibration and maintenance, it is not intended for single-use applications. Reuse is supported under the condition that it adheres to regulatory standards for X-ray imaging safety and performance.

• What types of X-ray imaging systems does the Canon CXDI-22 replace, and how does it differ from traditional film/screen systems?

  The Canon CXDI-22 replaces traditional film/screen radiographic systems by converting X-ray exposure directly into digital signals. Unlike film-based systems, it provides immediate viewing and analysis of images without the need for chemical processing or physical film handling, improving efficiency and reducing waste.

• How is the Canon CXDI-22 regulated in the U.S., and what does its classification mean for purchasing or clinical use?

  The Canon CXDI-22 is classified as a Class II medical device under the FDA’s Radiology advisory committee and holds a 510(k) clearance (K992547). This classification means it is subject to special controls, including performance standards and post-market surveillance, ensuring it meets safety and effectiveness requirements for X-ray imaging. Purchasers should confirm compliance with FDA regulations and manufacturer guidelines for installation and maintenance.

• Does the Canon CXDI-22 require any special handling or storage conditions?

  While the device data does not specify exact storage conditions, as a reusable medical instrument, the Canon CXDI-22 must be maintained in a controlled environment to ensure proper calibration and performance. It is not described as sterile upon delivery, so clinical protocols for cleaning, disinfection, and storage (e.g., protected from dust, moisture, or physical damage) should follow radiology best practices.

• Are there different models or sizes available for the Canon CXDI-22, or is it a single standardized unit?

  The provided data only references the CXDI-22 model explicitly, with no mention of alternative sizes or variants. It is classified under the Solid State X-Ray Imager (Flat Panel/Digital Imager) category, suggesting it is a standardized unit designed for general radiology use. For specific configurations or accessories, consult Canon’s technical documentation or support resources.