510(k) K944978

BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI by Bennett X-Ray Corp. — Product Code IZH

K944978 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI". The FDA issued a decision of Substantially Equivalent on May 3, 1995. 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.