510(k) K022292

IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO by Agfa Corp. — Product Code LLZ

K022292 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO". The FDA issued a decision of Substantially Equivalent on September 12, 2002. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Agfa Corp. has at least 10 other 510(k) clearances on record.