
Hitachi Medical Corp.
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EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER is an FDA 510(k)-cleared medical device (K053258) manufactured by Hitachi Medical Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2005. Regulation: 8.