510(k) K913012

DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES by Eigen — Product Code JAA

K913012 is an FDA 510(k) premarket notification submitted by Eigen for the device "DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Eigen has at least 10 other 510(k) clearances on record.