510(k) K994431

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES by Shimadzu Medical Systems — Product Code JAK

K994431 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES". The FDA issued a decision of Substantially Equivalent on March 23, 2000. 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.