Digital Radiography, Model CXDI-55C
FDA 510(k)Class II (US FDA 510(k))
by Canon Inc.
Identifiers
- 510(k) Number
- K091436 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, Model CXDI-55C is a solid-state X-ray imager, also known as a flat panel digital imager, used for capturing digital radiographic images. It is a device type classified as digital radiography.
The device is supplied as a single-use item. It is intended for use in radiology. The device is not MRI safe. The device is not sterilized. The device is not reusable.
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 Digital Radiography Systems | Canon Medical Systems USA, PDF _CXDI-55C_0135W514.qxd - Canon Canada, CXDI-55C - Canon Medical System U.S.A - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091436 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (1)
- FDA 510(k) K091436 24 fields · synced Sep 25, 2026