510(k) K900683

SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND by Hitachi Medical Corp. of America — Product Code ITX

K900683 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND". The FDA issued a decision of Substantially Equivalent on August 31, 1990. 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.