510(k) K143257

KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System by Medicatech USA — Product Code KPR

K143257 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System". The FDA issued a decision of Substantially Equivalent on February 6, 2015. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.