510(k) K050190

APOLLO by Villa Sistemi Medicali S.P.A. — Product Code KXJ

K050190 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "APOLLO". The FDA issued a decision of Substantially Equivalent on March 25, 2005. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.