510(k) K990055

B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 by Omega Medical Imaging, Inc. — Product Code JAA

K990055 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "B-400 CEILING MOUNTED POSSITIONER, MODEL B-400". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Omega Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.