510(k) K170113

pixium 4343RCE by Philips Medical Systems Dmc GmbH — Product Code MQB

K170113 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "pixium 4343RCE". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.