510(k) K950667

AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER by Chicago X-Ray Systems, Inc. — Product Code EAP

K950667 is an FDA 510(k) premarket notification submitted by Chicago X-Ray Systems, Inc. for the device "AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER". The FDA issued a decision of Substantially Equivalent on April 6, 1995. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Chicago X-Ray Systems, Inc. has at least 3 other 510(k) clearances on record.