510(k) K232178

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) by DRGEM Corporation — Product Code KPR

K232178 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)". The FDA issued a decision of Substantially Equivalent on September 19, 2023. 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.