Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

The Alphenix INFX-8000V/B/S V9.6 with aEvolve Imaging is an interventional X-ray fluoroscopic system used for diagnostic and angiographic procedures of blood vessels in the heart, brain, abdomen, and lower extremities. It features an Artificial Intelligence Denoising (AID) algorithm and Multi-Frequency Processing (MFP) for real-time noise reduction in fluoroscopic images for adult patients.

The subject device extends aEvolve Imaging field-of-view support to include 12-inch and 10-inch (binning mode) and 3-inch (hi-def, non-binning) FOVs, compared to the predicate's 8-inch and 6-inch (non-binning) FOVs. Both devices use the same basic C-arm interventional X-ray system architecture with comparable hardware and imaging chain components.

IEC 60601-1, IEC 60601-2-28, IEC 60601-2-43, IEC 62220-1-1:2015, IEC 62304, IEC 62366-1, IEC 81001-5-1, ISO 17664-2, and 21 CFR 1020 (Federal Diagnostic X-ray Equipment Standard). Image quality testing included noise power spectrum, modulation transfer function, noise equivalent quanta, low contrast detectability, and contrast-to-noise ratio measurements.

The subject device performs substantially equivalent imaging to the predicate device with the same intended use for diagnostic and angiographic procedures. The expanded FOV support for aEvolve Imaging represents a software/algorithm modification that bench testing demonstrates provides equivalent or superior image quality metrics (noise, contrast detection, and spatial resolution) compared to the predicate device.