510(k) K011141

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC by Shimadzu Corp. — Product Code JAK

K011141 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC". The FDA issued a decision of Substantially Equivalent on July 3, 2001. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shimadzu Corp. has at least 10 other 510(k) clearances on record.