Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

The Alphenix INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging is a digital radiography/fluoroscopy system used for diagnostic and interventional angiography procedures on blood vessels in the heart, brain, abdomen, and lower extremities. It includes an AI-based denoising (AID) algorithm and Multi Frequency Processing (MFP) signal enhancement intended for adult patients to reduce noise in real-time fluoroscopic images.

The subject device adds three key components not present in the V9.5 predicate: software to support αEvolve Imaging with AI denoising, a Stylish Design Cover (XGSD-120H/B1), and a Deep Learning Server (XIDF-DLS801). The AID algorithm replaces the predicate's Super Noise Reduction Filter (SNRF) and demonstrates improved performance in noise reduction, signal-to-noise ratio, contrast-to-noise ratio, modulation transfer function, and image lag while maintaining structural similarity.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 62304, IEC 62366-1, IEC 81001-5-1, ISO 17664-2, IEC TR 60601-4-2, and 21 CFR 1020 (Federal Diagnostic X-ray Equipment Standard).

The subject device is substantially equivalent to the V9.5 predicate because it performs the same intended use with the same indications and system configuration. Bench testing demonstrated the AID algorithm provides equal or superior image quality performance compared to SNRF across multiple metrics (noise, signal preservation, contrast, spatial resolution). Clinical reader studies with board-certified interventional cardiologists confirmed statistically significant superiority of AID imaging regarding sharpness, contrast, confidence, noise, and artifact absence. The device meets all applicable safety standards and regulatory requirements, demonstrating that the functional improvements do not raise new safety or effectiveness concerns.