510(k) K982060

VOLUMAX CT IMAGING SYSTEM by Elscint, Inc. — Product Code JAK

K982060 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "VOLUMAX CT IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 2, 1998. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Elscint, Inc. has at least 10 other 510(k) clearances on record.