510(k) K251602

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging by Canon Medical Systems Corporation — Product Code OWB

K251602 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Canon Medical Systems Corporation has at least 10 other 510(k) clearances on record.