510(k) K121577

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM by Toshiba Medical Systems Corporation, Japan — Product Code IYN

K121577 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 22, 2012. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.