510(k) K052095

MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 by Konica Minolta Medical & Graphic, Inc. — Product Code MQB

K052095 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190". The FDA issued a decision of Substantially Equivalent on November 3, 2005. 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.