510(k) K961690

CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 by Continental X-Ray Corp. — Product Code JAA

K961690 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105". The FDA issued a decision of Substantially Equivalent on June 27, 1996. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.