510(k) K854459

TBX MEDICAL X-RAY TABLE by Gendex Corp. — Product Code IXJ

K854459 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "TBX MEDICAL X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Gendex Corp. has at least 10 other 510(k) clearances on record.