510(k) K214030

Universal DR 1748 by Konica Minolta Healthcare Americas, Inc. — Product Code MQB

K214030 is an FDA 510(k) premarket notification submitted by Konica Minolta Healthcare Americas, Inc. for the device "Universal DR 1748". The FDA issued a decision of Substantially Equivalent on January 21, 2022. 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 Healthcare Americas, Inc. has at least 5 other 510(k) clearances on record.