510(k) K912516

CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 by Continental X-Ray Corp. — Product Code IZZ

K912516 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.