SOFTWARE RELEASE 4.2P, ACCESS(TM)

SOFTWARE RELEASE 4.2P, ACCESS(TM) is an FDA 510(k)-cleared medical device (K902310) manufactured by Toshiba America Mri, 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 July 31, 1990. Regulation: 8.