510(k) K102408

DIGITAL DIAGNOSTIC X-RAY SYSTEM by DRGEM Corporation — Product Code KPR

K102408 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "DIGITAL DIAGNOSTIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 2010. 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.