DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Canon Inc.
Identity
- Trade Name
- DIGITAL RADIOGRAPHY CXDI-702C Wireless EUDAMEDCANON INC. FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- CXDI-Pro EUDAMED
- Model / Reference
- Digital Radiography EUDAMEDBT8-1910 EUDAMEDCXDI-702C Wireless FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292167436 EUDAMEDFDA UDI
- Basic UDI-DI
- 4549292dr01CU EUDAMED
- 510(k) Number
- FDA Product Code
- MQB FDA 510(k)FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The CXDI-702C Wireless and CXDI-402C Wireless are Solid State X-Ray Imagers (Flat Panel/Digital Imager), designed for digital radiography. These devices capture high-resolution radiographic images using wireless flat-panel detectors, enabling efficient and flexible imaging workflows in clinical settings. Their construction incorporates solid-state technology to convert X-ray exposure into digital signals for immediate display and analysis.
These systems are intended for use in radiology departments, where they are supplied as reusable medical devices. The CXDI-702C and CXDI-402C feature Automatic Exposure Detection (AED), eliminating the need for traditional wired generator interfaces and streamlining workflows. They are non-MRI-safe and require proper storage in a clean, dry environment to maintain performance. Authorized under FDA 510K and MDR, these devices adhere to regulatory standards for digital radiography imaging systems.
Frequently asked questions
Are these devices single-use or reusable, and what does that mean for maintenance and workflow in a radiology department?
The CXDI-702C Wireless and CXDI-402C Wireless are reusable medical devices, meaning they are designed for repeated use across multiple patients. Since they are not single-use, your radiology department will need to establish a cleaning, disinfection, and maintenance protocol to ensure proper functionality and infection control between uses. Their wireless design and solid-state technology simplify workflows by eliminating the need for wired connections, but regular servicing will be required to maintain image quality and reliability over time.
How should these devices be stored to maintain their performance and longevity?
The CXDI-702C and CXDI-402C should be stored in a clean, dry environment to preserve their performance. Since they are reusable and sensitive electronic devices, exposure to moisture, dust, or extreme temperatures could damage the flat-panel detectors or internal components. Proper storage also helps prevent physical wear and ensures the wireless connectivity remains reliable for clinical use.
What regulatory pathways have these devices undergone, and what does that mean for purchasing or implementing them in a clinical setting?
These devices are authorized under FDA 510K and the EU Medical Device Regulation (MDR), confirming they meet regulatory standards for digital radiography imaging systems. The FDA clearance was granted through a Special 510(k) process, with the device deemed *substantially equivalent* to a predicate, and the MDR approval aligns with EU safety and performance requirements. For purchasing or implementation, this means they comply with key international and U.S. regulatory frameworks, though your facility should verify local compliance requirements before integration.
Are these devices safe to use in an MRI environment, and if not, what precautions should be taken?
The CXDI-702C and CXDI-402C are not MRI-safe, meaning they should not be used or stored in an MRI environment. The wireless flat-panel detectors contain electronic components that could be affected by magnetic fields, posing a risk to both the device and patients undergoing MRI scans. If your facility has an MRI suite, these devices must be kept in a separate, designated area to avoid accidental exposure.
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: PDF CXDI-702C Wireless CXDI-402C Wireless - mce.canon, Canon CXDI-702 Wireless Flat Panel Detector - Canon Medical Components ..., Product Details - mcu.canon, CXDI-702C and CXDI-402C Wireless Digital Radiography Systems | CXDI ...
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 | K192632 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (3)
- FDA 510(k) K192632 24 fields · synced Sep 18, 2026
- FDA UDI 9d2694fa-b66c-4113-a51f-04e47721701b 34 fields · synced May 30, 2026
- EUDAMED 53c9aaa1-7cc0-49d8-90cd-e4d7dd06510e 61 fields · synced Jul 27, 2026