510(k) K952456

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM by Fisher Imaging Corp. — Product Code JAA

K952456 is an FDA 510(k) premarket notification submitted by Fisher Imaging Corp. for the device "IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 1995. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Fisher Imaging Corp. has at least 2 other 510(k) clearances on record.