510(k) K881386

X-RAY GENERATING SYSTEM TF 1000 by General Medical Merate S.P.A — Product Code IZO

K881386 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "X-RAY GENERATING SYSTEM TF 1000". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. General Medical Merate S.P.A has at least 6 other 510(k) clearances on record.