510(k) K160301

Platinum dRF Imaging System by Apelem-Dms Group — Product Code JAA

K160301 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 Mar 4, 2016. 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.