EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER is an FDA 510(k)-cleared medical device (K862164) manufactured by Hitachi Medical Corp. of America. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 1986. Regulation: 8.