510(k) K022658

LR DICOM CONTROLLER by Agfa Corp. — Product Code LMC

K022658 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "LR DICOM CONTROLLER". The FDA issued a decision of Substantially Equivalent on September 6, 2002. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Agfa Corp. has at least 10 other 510(k) clearances on record.