510(k) K920349

PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR by Control-X, Inc. — Product Code IZO

K920349 is an FDA 510(k) premarket notification submitted by Control-X, Inc. for the device "PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Control-X, Inc. has at least 8 other 510(k) clearances on record.