510(k) K211782

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 by Controlrad, Inc. — Product Code OWB

K211782 is an FDA 510(k) premarket notification submitted by Controlrad, Inc. for the device "ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9". The FDA issued a decision of Substantially Equivalent on July 1, 2021. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Controlrad, Inc. has at least 5 other 510(k) clearances on record.