510(k) K253288

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) by Esaote, S.p.A. — Product Code IYN

K253288 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)". The FDA issued a decision of Substantially Equivalent on April 6, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Esaote, S.p.A. has at least 10 other 510(k) clearances on record.