510(k) K874946

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 by Shimadzu Precision Instruments, Inc. — Product Code IZO

K874946 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60". The FDA issued a decision of Substantially Equivalent on March 3, 1988. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.