510(k) K153318

Philips Eleva Workspot with SkyFlow by Philips Medical Systems Dmc GmbH — Product Code MQB

K153318 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Philips Eleva Workspot with SkyFlow". The FDA issued a decision of Substantially Equivalent on December 22, 2015. 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.