510(k) K864837

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM by Oec-Diasonics, Inc. — Product Code JAA

K864837 is an FDA 510(k) premarket notification submitted by Oec-Diasonics, Inc. for the device "MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM". The FDA issued a decision of Substantially Equivalent on January 30, 1987. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Oec-Diasonics, Inc. has at least 7 other 510(k) clearances on record.