510(k) K780769

S-100 CT SCANNER by Syntex Corp. — Product Code JAK

K780769 is an FDA 510(k) premarket notification submitted by Syntex Corp. for the device "S-100 CT SCANNER". The FDA issued a decision of Substantially Equivalent on June 2, 1978. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Syntex Corp. has at least 9 other 510(k) clearances on record.