Digital Radiography CXDI-Pro D1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Canon Inc.
Identifiers
- 510(k) Number
- K212553 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital Radiography CXDI-Pro D1 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for high-resolution digital radiographic imaging. It employs a wireless flat panel detector to capture and transmit radiographic images, enabling efficient workflow integration in clinical settings. The device leverages advanced solid-state technology to deliver precise diagnostic imaging for various radiographic procedures.
This device is intended for use in radiology departments, where it is supplied as a reusable, non-sterile medical instrument. It is classified as Class II under FDA regulations and has received FDA 510K clearance and MDR authorization. The CXDI-Pro D1 is compatible with multiple imaging systems and features lightweight construction using carbon fiber for enhanced portability. Storage and handling follow standard radiology protocols to ensure optimal performance and image quality.
Frequently asked questions
Is the Canon CXDI-Pro D1 detector reusable or single-use, and how does this affect its use in a clinical setting?
The Canon CXDI-Pro D1 is designed as a reusable device, meaning it is not intended for single-use. Since it is non-sterile, it must be cleaned and maintained according to standard radiology protocols between uses to ensure hygiene and optimal performance. Its durable construction, including lightweight carbon fiber materials, supports repeated use while maintaining image quality and workflow efficiency in radiology departments.
What types of radiographic procedures is the CXDI-Pro D1 intended to support, and how does its wireless design improve workflow?
The CXDI-Pro D1 is a wireless flat-panel detector intended for high-resolution digital radiographic imaging, making it suitable for a wide range of radiographic procedures in clinical settings. Its wireless capability eliminates the need for cables, reducing clutter and improving mobility for radiologists and technicians. This design streamlines workflow by allowing seamless image transmission to compatible imaging systems, enhancing efficiency in busy radiology departments.
How should the CXDI-Pro D1 be stored to maintain its performance and image quality over time?
The CXDI-Pro D1 should be stored following standard radiology protocols to preserve its functionality and image quality. Since it is a reusable, non-sterile device, storage should be in a clean, dry environment protected from physical damage, extreme temperatures, or moisture. Proper handling and maintenance, as outlined in Canon’s guidelines, are essential to ensure consistent performance and longevity of the detector.
What regulatory pathways has the CXDI-Pro D1 undergone, and what does this mean for its use in healthcare settings?
The CXDI-Pro D1 has received FDA 510K clearance and MDR authorization, confirming its compliance with regulatory standards in the U.S. and European markets. These approvals indicate that the device has been evaluated for safety and effectiveness as a Class II medical device under FDA regulations, ensuring it meets stringent requirements for use in radiology departments. Clinicians can rely on its regulatory backing for clinical applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CXDI-Pro Series Digital Radiography | Canon Medical Systems USA, CXDI Digital Radiography Systems | Canon Medical Systems USA, PDF DIGITAL RADIOGRAPHY CXDI-Pro - mce.canon
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212553 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (2)
- FDA 510(k) K212553 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026