510(k) K163210

Philips CombiDiagnost R90 by Philips Medical Systems Dmc GmbH — Product Code JAA

K163210 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Philips CombiDiagnost R90". The FDA issued a decision of Substantially Equivalent on January 31, 2017. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.