510(k) K973329

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX by Shimadzu Medical Systems — Product Code JAK

K973329 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX". The FDA issued a decision of Substantially Equivalent on October 8, 1997. 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.