Scatter Correction for CXDI Series
FDA 510(k)Class II (US FDA 510(k))
by Canon Inc.
Identifiers
- 510(k) Number
- K153312 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)
This device is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed to reduce the impact of scattered radiation in non-grid bedside examinations. It enhances image contrast by mitigating scatter artifacts, improving diagnostic quality without requiring a physical grid.
The Scatter Correction for CXDI Series is integrated into the CXDI Control Software NE and is intended for use with compatible CXDI detectors. It is a non-sterile, reusable software-based solution, classified as Class II under FDA regulations (K153312, 510(k) clearance). No MRI safety or specific size constraints are noted in the data.
Frequently asked questions
What is the purpose of the Scatter Correction for CXDI Series?
This device is designed to reduce the impact of scattered radiation in non-grid bedside examinations, enhancing image contrast by mitigating scatter artifacts and improving diagnostic quality without requiring a physical grid.
How is the Scatter Correction for CXDI Series supplied?
It is integrated into the CXDI Control Software NE and is intended for use with compatible CXDI detectors, making it a software-based solution rather than a physical device.
Is the Scatter Correction for CXDI Series sterile or single-use?
The device is non-sterile and reusable as it is a software-based solution, not a physical medical device that would require sterility or be designated for single-use.
What are the regulatory requirements for the Scatter Correction for CXDI Series?
It is classified as Class II under FDA regulations with K153312 510(k) clearance, indicating it has been determined to be substantially equivalent to existing devices.
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: Scatter Correction - mcu.canon, Canon Scatter Correction - Canon Medical Components Europe, Scatter Correction - eu.medical.canon, PDF K153312 - Scatter Correction for Cxdi Series
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153312 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (1)
- FDA 510(k) K153312 24 fields · synced Sep 19, 2026