510(k) K002432

STRATO X by Villa Sistemi Medicali S.P.A. — Product Code EHD

K002432 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "STRATO X". The FDA issued a decision of Substantially Equivalent on September 1, 2000. 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.