510(k) K110870

APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C — Product Code IYN

K110870 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on October 4, 2011. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.