510(k) K040688

STANDARD IMAGING E.IMRT CALCULATOR by Standard Imaging, Inc. — Product Code MUJ

K040688 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STANDARD IMAGING E.IMRT CALCULATOR". The FDA issued a decision of Substantially Equivalent on May 11, 2004. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.