510(k) K053634

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION by Agfa Corporation — Product Code MQB

K053634 is an FDA 510(k) premarket notification submitted by Agfa Corporation for the device "COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION". The FDA issued a decision of Substantially Equivalent on January 17, 2006. 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 Corporation has at least 3 other 510(k) clearances on record.