510(k) K050704

MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING by General Electric Co. — Product Code KPR

K050704 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING". The FDA issued a decision of Substantially Equivalent on April 8, 2005. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. General Electric Co. has at least 10 other 510(k) clearances on record.