510(k) K041580

IMAGERAYI by Henry Schein, Inc. — Product Code MUH

K041580 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "IMAGERAYI". The FDA issued a decision of Substantially Equivalent on June 29, 2004. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.