510(k) K262115

VueJect® Ultrasound Enhancing Agent Delivery System by ACIST Medical Systems, Inc. — Product Code IZQ

K262115 is an FDA 510(k) premarket notification submitted by ACIST Medical Systems, Inc. for the device "VueJect® Ultrasound Enhancing Agent Delivery System". The FDA issued a decision of Substantially Equivalent on August 3, 2026. The device falls under product code IZQ (Injector, Contrast Medium, Automatic), a Class II device regulated under 21 CFR 870.1650. ACIST Medical Systems, Inc. has at least 10 other 510(k) clearances on record.