EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER

EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER is an FDA 510(k)-cleared medical device (K994026) 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 March 28, 2000. Regulation: 8.