510(k) K851011

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR by Hofmann X-Ray of America, Inc. — Product Code IZO

K851011 is an FDA 510(k) premarket notification submitted by Hofmann X-Ray of America, Inc. for the device "HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Hofmann X-Ray of America, Inc. has at least 1 other 510(k) clearance on record.