510(k) K954666

MPH50, MPH65, AND MPH80 by GE Medical Systems — Product Code IZO

K954666 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "MPH50, MPH65, AND MPH80". The FDA issued a decision of Substantially Equivalent on November 24, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. GE Medical Systems has at least 10 other 510(k) clearances on record.