510(k) K860203

TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR by Tingle X-Ray Products, Inc. — Product Code IZO

K860203 is an FDA 510(k) premarket notification submitted by Tingle X-Ray Products, Inc. for the device "TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR". The FDA issued a decision of Substantially Equivalent on January 30, 1986. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Tingle X-Ray Products, Inc. has at least 2 other 510(k) clearances on record.