VERSION 3.7 OPERATING SYSTEM SOFTWARE

VERSION 3.7 OPERATING SYSTEM SOFTWARE is an FDA 510(k)-cleared medical device (K960181) manufactured by Hitachi Medical Systems America, Inc.. 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 4, 1996. Regulation: 8.