510(k) K253310

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) by Esaote, S.p.A. — Product Code IYN

K253310 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)". The FDA issued a decision of Substantially Equivalent on November 25, 2025. 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.