510(k) K925094

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS by Gendex Corp. — Product Code EHD

K925094 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS". The FDA issued a decision of Substantially Equivalent on September 29, 1993. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Gendex Corp. has at least 10 other 510(k) clearances on record.