510(k) K182134

ARiX RAD Radiographic System by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. — Product Code KPR

K182134 is an FDA 510(k) premarket notification submitted by Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. for the device "ARiX RAD Radiographic System". The FDA issued a decision of Substantially Equivalent on Nov 26, 2018. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. has 3 other 510(k) clearances on record.