510(k) K041605

PRECISION RXI ANALOG X-RAY SYSTEM by General Medical Merate S.P.A — Product Code OWB

K041605 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "PRECISION RXI ANALOG X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 2004. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. General Medical Merate S.P.A has at least 6 other 510(k) clearances on record.