510(k) K212960

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation — Product Code IYN

K212960 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5". The FDA issued a decision of Substantially Equivalent on Mar 22, 2022. 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 96 other 510(k) clearances on record.