510(k) K111304

OPTIMA XR120 by Ge Medical Systems, LLC — Product Code IXL

K111304 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "OPTIMA XR120". The FDA issued a decision of Substantially Equivalent on July 19, 2011. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.