510(k) K981992

ELECTRON WEDGE MODEL MT-EW-1000 by Med-Tec,Inc. — Product Code IXI

K981992 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "ELECTRON WEDGE MODEL MT-EW-1000". The FDA issued a decision of Substantially Equivalent on December 15, 1998. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.