510(k) K183541

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems by Prognosys Medical Systems Private Limited — Product Code KPR

K183541 is an FDA 510(k) premarket notification submitted by Prognosys Medical Systems Private Limited for the device "ProRad 2FC and ProRad 3NC Stationary Radiographic Systems". The FDA issued a decision of Substantially Equivalent on January 24, 2019. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Prognosys Medical Systems Private Limited has at least 2 other 510(k) clearances on record.