510(k) K260589

ES-Series by E-Scopics — Product Code IYN

K260589 is an FDA 510(k) premarket notification submitted by E-Scopics for the device "ES-Series". The FDA issued a decision of Substantially Equivalent on April 29, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. E-Scopics has at least 3 other 510(k) clearances on record.