510(k) K123005

DDRVERSA MOTION by Swissray Medical AG — Product Code MQB

K123005 is an FDA 510(k) premarket notification submitted by Swissray Medical AG for the device "DDRVERSA MOTION". The FDA issued a decision of Substantially Equivalent on Dec 7, 2012. 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. Swissray Medical AG has at least 3 other 510(k) clearances on record.