510(k) K081963

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS by Agfa Healthcare Corporation — Product Code MQB

K081963 is an FDA 510(k) premarket notification submitted by Agfa Healthcare Corporation for the device "AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS". The FDA issued a decision of Substantially Equivalent on July 25, 2008. 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. Agfa Healthcare Corporation has at least 4 other 510(k) clearances on record.