510(k) K082243

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

K082243 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 7, 2008. 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.