VISITRAK, VERSION 1, RELEASE 1

VISITRAK, VERSION 1, RELEASE 1 is an FDA 510(k)-cleared medical device (K050372) manufactured by Math Resolutions, LLC. 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 24, 2005. Regulation: 8.