ACCESS(TM), SOFTWARE RELEASE 4.11P

ACCESS(TM), SOFTWARE RELEASE 4.11P is an FDA 510(k)-cleared medical device (K896637) manufactured by Diasonics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1990. Regulation: 8.