510(k) K950571

LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 by Continental X-Ray Corp. — Product Code IZF

K950571 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.