510(k) K092717

DIRECT DIGITIZER, REGIUS MODEL 210 by Konica Minolta Medical & Graphic, Inc. — Product Code MQB

K092717 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "DIRECT DIGITIZER, REGIUS MODEL 210". The FDA issued a decision of Substantially Equivalent on October 30, 2009. 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. Konica Minolta Medical & Graphic, Inc. has at least 10 other 510(k) clearances on record.