ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 is an FDA 510(k)-cleared medical device (K211782) manufactured by Controlrad, 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 June 30, 2021. Regulation: 8.