510(k) K010449

IVD (IN VIVO DOSIMETER), MODEL 1131 by Sun Nuclear Corp. — Product Code IYE

K010449 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "IVD (IN VIVO DOSIMETER), MODEL 1131". The FDA issued a decision of Substantially Equivalent on May 4, 2001. 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.