510(k) K101992

3D SCANNER, MODEL 1230 by Sun Nuclear Corp. — Product Code IYE

K101992 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "3D SCANNER, MODEL 1230". The FDA issued a decision of Substantially Equivalent on October 1, 2010. 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.