Digital Radiography CXDI-401C Wireless
FDA 510(k)Class II (US FDA 510(k))
by Canon Inc.
Identifiers
- 510(k) Number
- K133693 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)
Digital Radiography CXDI-401C Wireless is a solid state X-ray imager (flat panel/digital imager) used in radiology. It is a wireless digital radiography system designed for capturing radiographic images.
The device is supplied as a wireless digital radiography system and is authorized under FDA 510(k) clearance K133693. It is classified as a Class II medical device under regulation number 892.1680 with product code MQB.
Frequently asked questions
What is the DIGITAL RADIOGRAPHY CXDI-401C WIRELESS used for?
The DIGITAL RADIOGRAPHY CXDI-401C WIRELESS is a solid state X-ray imager (flat panel/digital imager) used in radiology to capture radiographic images. It functions as a wireless digital radiography system designed specifically for radiographic imaging in clinical settings.
How is the DIGITAL RADIOGRAPHY CXDI-401C WIRELESS supplied and authorized?
The device is supplied as a wireless digital radiography system and is authorized under FDA 510(k) clearance K133693. It is classified as a Class II medical device under regulation number 892.1680 with product code MQB, indicating it underwent a traditional 510(k) submission process and was found substantially equivalent to a predicate device.
Is the DIGITAL RADIOGRAPHY CXDI-401C WIRELESS a reusable or single-use device?
The DIGITAL RADIOGRAPHY CXDI-401C WIRELESS is a reusable solid state X-ray imager designed for repeated use in radiographic imaging. As a wireless digital radiography system, it is intended for multiple clinical uses after appropriate cleaning and maintenance, consistent with its classification as a durable medical imaging device under FDA 510(k) clearance.
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-401C Wireless, CXDI-401C COMPACT - mcu.canon, CXDI-401C Compact CXDI-401G Compact - canon.a.bigcontent.io, PDF CXDI-01 SERIES WIRELESS - brownsmedicalimaging.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133693 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (1)
- FDA 510(k) K133693 24 fields · synced Sep 25, 2026