510(k) K942731

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR by Shimadzu Corp. — Product Code IZO

K942731 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR". The FDA issued a decision of Substantially Equivalent on October 13, 1994. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Shimadzu Corp. has at least 10 other 510(k) clearances on record.