510(k) K090749

ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 by Villa Sistemi Medicali S.P.A. — Product Code EHD

K090749 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191". The FDA issued a decision of Substantially Equivalent on May 18, 2009. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), 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.