510(k) K981131

PATHFINDER MOBILE C ARM by Acoma Medical Imaging, Inc. — Product Code OXO

K981131 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "PATHFINDER MOBILE C ARM". The FDA issued a decision of Substantially Equivalent on June 26, 1998. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.