Cleared Traditional

K833558 - X-RAY SHIELD (FDA 510(k) Clearance)

Class I Radiology device.

K833558 · Moyco Industries, Inc. · Radiology device
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Jan 1984
Decision
92d
Days
Class 1
Risk

K833558 is an FDA 510(k) clearance for the X-RAY SHIELD. Classified as Collimator, X-ray (product code EHB), Class I - General Controls.

Submitted by Moyco Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1840 - 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 Moyco Industries, Inc. devices

Submission Details

510(k) Number K833558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1983
Decision Date January 13, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHB Collimator, X-ray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.1840
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.