510(k) K875370

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX by Shimadzu Precision Instruments, Inc. — Product Code JAK

K875370 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX". The FDA issued a decision of Substantially Equivalent on May 18, 1988. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.