510(k) K192364

GXR-Series Diagnostic X-Ray System by DRGEM Corporation — Product Code KPR

K192364 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "GXR-Series Diagnostic X-Ray System". The FDA issued a decision of Substantially Equivalent on September 26, 2019. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. DRGEM Corporation has at least 10 other 510(k) clearances on record.