510(k) K980837

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS by Shimadzu Medical Systems — Product Code JAK

K980837 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS". The FDA issued a decision of Substantially Equivalent on May 20, 1998. 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.