510(k) K024012

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM by Ge Oec Medical Systems — Product Code JAA

K024012 is an FDA 510(k) premarket notification submitted by Ge Oec Medical Systems for the device "OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2003. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Ge Oec Medical Systems has at least 10 other 510(k) clearances on record.