510(k) K051523

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION by Konica Minolta Medical & Graphic, Inc. — Product Code LLZ

K051523 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION". The FDA issued a decision of Substantially Equivalent on July 20, 2005. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Konica Minolta Medical & Graphic, Inc. has at least 10 other 510(k) clearances on record.