510(k) K031866

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC by Med-Tec,Inc. — Product Code JAI

K031866 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC". The FDA issued a decision of Substantially Equivalent on August 14, 2003. 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.