omni TRAX Active Patient Tracker

omni TRAX Active Patient Tracker is an FDA 510(k)-cleared medical device (K143396) manufactured by Civco Medical Instruments CO Inc Dba Civco Medical Solutions. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2015. Regulation: 8.