510(k) K984156

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION by Shimadzu Medical Systems — Product Code JAK

K984156 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION". The FDA issued a decision of Substantially Equivalent on April 21, 1999. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.