Cleared Traditional

K926445 - SOYEE ALUMINUM INTERSPACED X-RAY GRID (FDA 510(k) Clearance)

Class I Radiology device.

K926445 · X-Ray Accessories Mfg. Co. · Radiology device
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Apr 1993
Decision
105d
Days
Class 1
Risk

K926445 is an FDA 510(k) clearance for the SOYEE ALUMINUM INTERSPACED X-RAY GRID. Classified as Grid, Radiographic (product code IXJ), Class I - General Controls.

Submitted by X-Ray Accessories Mfg. Co. (Putnam, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 105 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 X-Ray Accessories Mfg. Co. devices

Submission Details

510(k) Number K926445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date April 07, 1993
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.