510(k) K252074

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System by Canon Medical Systems Corporation — Product Code IYN

K252074 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on October 31, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Canon Medical Systems Corporation has at least 10 other 510(k) clearances on record.