Intelligent NR

The Intelligent NR is software (part of CXDI Control Software v3.13) that reduces noise in X-ray images using machine-learning algorithms trained on clinical image databases. It works with Canon detectors to provide digital image capture, processing, and display for general radiographic and fluoroscopic examinations, replacing film/screen systems and image intensifiers. It is not intended for mammography.

The key technological difference is the addition of an Intelligent NR function for dynamic imaging (fluoroscopy), which uses machine-learning algorithms to automatically reduce image noise. The same algorithm was previously used in a reference device for radiography. The proposed device maintains contrast transfer function (CTF), preserves spatial resolution, and improves contrast-to-noise ratio (CNR) by approximately 1.1 to 1.5 times compared to conventional noise reduction.

The device complies with IEC 62304:2015 (medical device software lifecycle processes). Compatible detectors comply with the U.S. Performance Standard for radiographic equipment and IEC standards 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32 for electrical safety and electromagnetic compatibility.

Substantial equivalence is based on similarities in application/intended use, principles of operation, and functional design to the predicate device (DIGITAL RADIOGRAPHY CXDI-RF Wireless B1). Verification/validation testing demonstrated the device is safe and effective, performs comparably to the predicate, and the addition of Intelligent NR does not introduce new questions regarding safety or effectiveness. All identified risks were successfully mitigated through FMEA analysis.