510(k) K131766

PLATINUM DRF IMAGING SYSTEM by Apelem-Dms Group — Product Code JAA

K131766 is an FDA 510(k) premarket notification submitted by Apelem-Dms Group for the device "PLATINUM DRF IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 2013. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Apelem-Dms Group has at least 2 other 510(k) clearances on record.