Intended Use

The CXDI Control Software when used with a compatible Canon detector provides digital image capture, processing, display for conventional film/screen radiographic examinations including fluoroscopic images. Intelligent NR utilizes AI-based algorithms to reduce noise in fluoroscopic images.

Technology

Intelligent NR is a part of Canon's CXDI Control Software (version 3.13), which uses a machine learning algorithm trained on clinical image databases to reduce noise in fluoroscopic X-ray images. It operates on a PC without further learning after release and works with compatible Canon detectors without firmware changes.

Performance

Performance testing included verification/validation against internal specifications, qualitative and quantitative image comparisons. Intelligent NR improved contrast-to-noise ratio between 1.1-1.5 times without degrading spatial resolution. Reader studies by independent physicians confirmed improved image quality and safety. Risk analysis and cybersecurity controls were also conducted, demonstrating substantial equivalence and safety.

Predicate Devices

No predicate devices specified

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