510(k) K952822

SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G by Shimadzu Corp. — Product Code IZO

K952822 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G". The FDA issued a decision of Substantially Equivalent on July 12, 1995. 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.