510(k) K885135

MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 by Bennett X-Ray Corp. — Product Code IZH

K885135 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150". The FDA issued a decision of Substantially Equivalent on March 9, 1989. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.