510(k) K082773

STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 by Standard Imaging, Inc. — Product Code IYE

K082773 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331". The FDA issued a decision of Substantially Equivalent on November 19, 2008. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.