510(k) K111152

ROTOGRAPH EVO 3D by Villa Sistemi Medicali S.P.A. — Product Code MUH

K111152 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "ROTOGRAPH EVO 3D". The FDA issued a decision of Substantially Equivalent on July 22, 2011. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.