510(k) K232526

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 by Canon Medical Systems Corporation — Product Code JAA

K232526 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5". The FDA issued a decision of Substantially Equivalent on September 12, 2023. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Canon Medical Systems Corporation has at least 10 other 510(k) clearances on record.