VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE

VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE is an FDA 510(k)-cleared medical device (K081076) manufactured by Velocity Medical Solutions, 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 June 19, 2008. Regulation: 8.