Cleared Traditional

K854459 - TBX MEDICAL X-RAY TABLE

K854459 is an FDA 510(k) clearance for TBX MEDICAL X-RAY TABLE, manufactured by Gendex Corp.. The device is a Class 1 Radiology device with product code IXJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K854459 · Gendex Corp. · Radiology device
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Feb 1986
Decision
98d
Days
Class 1
Risk

K854459 is an FDA 510(k) clearance for the TBX MEDICAL X-RAY TABLE. Classified as Grid, Radiographic (product code IXJ), Class I - General Controls.

Submitted by Gendex Corp. (Franklin Park, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1910 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gendex Corp. devices

FDA 510(k) Submission Details - K854459

510(k) Number K854459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1985
Decision Date February 12, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

IXJ Device Classification - Class 1, General Controls

Product Code IXJ Grid, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.