510(k) K960146

G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY by GE Medical Systems — Product Code IZG

K960146 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY". The FDA issued a decision of Substantially Equivalent on February 27, 1996. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. GE Medical Systems has at least 10 other 510(k) clearances on record.