510(k) K034054

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 by Med-Tec,Inc. — Product Code JAI

K034054 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.