510(k) K051921

THE EDGE DETECTOR, MODEL 1118 by Sun Nuclear Corp. — Product Code IYE

K051921 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "THE EDGE DETECTOR, MODEL 1118". The FDA issued a decision of Substantially Equivalent on July 27, 2005. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.