510(k) K994026

EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER by Hitachi Medical Corp. of America — Product Code IYN

K994026 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER". The FDA issued a decision of Substantially Equivalent on March 29, 2000. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.