510(k) K101935

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM by Centervue S.P.A. — Product Code HKI

K101935 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "CENTERVUE DIGITAL RETINOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 2010. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Centervue S.P.A. has at least 10 other 510(k) clearances on record.