510(k) K050751

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X by Agfa Corp. — Product Code LLZ

K050751 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X". The FDA issued a decision of Substantially Equivalent on April 21, 2005. 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.