510(k) K141192

DR 400 by Agfa Healthcare N.V. — Product Code MQB

K141192 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "DR 400". The FDA issued a decision of Substantially Equivalent on Jun 6, 2014. 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 N.V. has at least 10 other 510(k) clearances on record.