510(k) K243502

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) by Olympus Medical Systems Corporation — Product Code IYN

K243502 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.