Cleared Traditional

K922848 - ULTRALITE X-RAY FILM ILLUMINATOR (FDA 510(k) Clearance)

Class I Radiology device.

K922848 · A & S Trading Co. · Radiology device
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Sep 1992
Decision
102d
Days
Class 1
Risk

K922848 is an FDA 510(k) clearance for the ULTRALITE X-RAY FILM ILLUMINATOR. Classified as Illuminator, Radiographic-film (product code IXC), Class I - General Controls.

Submitted by A & S Trading Co. (Fort Mill, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1890 - 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.

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Submission Details

510(k) Number K922848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date September 28, 1992
Days to Decision 102 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
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXC Illuminator, Radiographic-film
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1890
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.