510(k) K953582

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR by Varian Canada, Inc. — Product Code IZO

K953582 is an FDA 510(k) premarket notification submitted by Varian Canada, Inc. for the device "HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Varian Canada, Inc. has at least 6 other 510(k) clearances on record.