510(k) K073695

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 by J. Morita USA, Inc. — Product Code JAK

K073695 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17". The FDA issued a decision of Substantially Equivalent on April 9, 2008. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.