SPECTRADIGITAL SERIES V250DSP

SPECTRADIGITAL SERIES V250DSP is an FDA 510(k)-cleared medical device (K954129) 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 December 21, 1995. Regulation: 8.