510(k) K041701

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM by Agfa Corp. — Product Code MQB

K041701 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 2004. 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 Corp. has at least 10 other 510(k) clearances on record.