510(k) K850614

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY by S & S X-Ray Products, Inc. — Product Code IZH

K850614 is an FDA 510(k) premarket notification submitted by S & S X-Ray Products, Inc. for the device "SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY". The FDA issued a decision of Substantially Equivalent on Mar 26, 1985. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. S & S X-Ray Products, Inc. has 3 other 510(k) clearances on record.