510(k) K092948

APLIO MX SSA-780A, VERSION 1.0 by Toshiba America Medical Systems, In.C — Product Code IYN

K092948 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "APLIO MX SSA-780A, VERSION 1.0". The FDA issued a decision of Substantially Equivalent on October 9, 2009. 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.