510(k) K130109

ENDOGRAPH DC by Villa Sistemi Medicali S.P.A. — Product Code EHD

K130109 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "ENDOGRAPH DC". The FDA issued a decision of Substantially Equivalent on August 1, 2013. 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.