Cleared Traditional

K833558 - X-RAY SHIELD

K833558 is an FDA 510(k) clearance for X-RAY SHIELD, manufactured by Moyco Industries, Inc.. The device is a Class 1 Radiology device with product code EHB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K833558

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.

EHB Device Classification - Class 1, General Controls

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.