510(k) K925133

DPD-510 THERAPEUTIC RADIATION DOSIMETER by Scanditronix, Inc. — Product Code IWB

K925133 is an FDA 510(k) premarket notification submitted by Scanditronix, Inc. for the device "DPD-510 THERAPEUTIC RADIATION DOSIMETER". The FDA issued a decision of Substantially Equivalent on January 4, 1993. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Scanditronix, Inc. has at least 6 other 510(k) clearances on record.