510(k) K110673

HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER by Hitachi Medical Systems America, Inc. — Product Code IYN

K110673 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER". The FDA issued a decision of Substantially Equivalent on September 27, 2011. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.