510(k) K052897

GE DEFINIUM AMX 700, MODEL AMX 700 by General Electric Medical Systems — Product Code IZL

K052897 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems for the device "GE DEFINIUM AMX 700, MODEL AMX 700". The FDA issued a decision of Substantially Equivalent on November 8, 2005. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. General Electric Medical Systems has at least 5 other 510(k) clearances on record.