510(k) K162954

OARtrac System with Patient Specific Reusable Universal PSD Sensors by Radiadyne, LLC — Product Code NZT

K162954 is an FDA 510(k) premarket notification submitted by Radiadyne, LLC for the device "OARtrac System with Patient Specific Reusable Universal PSD Sensors". The FDA issued a decision of Substantially Equivalent on June 1, 2017. The device falls under product code NZT (Dosimeter, Ionizing Radiation, Implanted), a Class II device regulated under 21 CFR 892.5050. Radiadyne, LLC has at least 4 other 510(k) clearances on record.