510(k) K972016

AUTIMO 2.5-D AND AUTIMO 3-D by C.L. Mcintosh & Assoc., Inc. — Product Code IXI

K972016 is an FDA 510(k) premarket notification submitted by C.L. Mcintosh & Assoc., Inc. for the device "AUTIMO 2.5-D AND AUTIMO 3-D". The FDA issued a decision of Substantially Equivalent on December 4, 1997. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. C.L. Mcintosh & Assoc., Inc. has at least 3 other 510(k) clearances on record.