510(k) K963888

C-ARM TABLE IVS-100 by Shimadzu Medical Systems — Product Code JAA

K963888 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "C-ARM TABLE IVS-100". The FDA issued a decision of Substantially Equivalent on December 18, 1996. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.