Cleared Traditional

K926261 - JPI ALUMINUM INTERSPACED X-RAY GRID (FDA 510(k) Clearance)

Class I Radiology device.

K926261 · Jpi, Inc. · Radiology device
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Mar 1993
Decision
90d
Days
Class 1
Risk

K926261 is an FDA 510(k) clearance for the JPI ALUMINUM INTERSPACED X-RAY GRID. Classified as Grid, Radiographic (product code IXJ), Class I - General Controls.

Submitted by Jpi, Inc. (Bohemia, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 90 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 Jpi, Inc. devices

Submission Details

510(k) Number K926261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date March 18, 1993
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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.