510(k) K912364

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED by Hitachi Medical Corp. of America — Product Code ITX

K912364 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED". The FDA issued a decision of Substantially Equivalent on August 26, 1992. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.