Cleared Traditional

K944445 - ED CORP RADIATION SCREEN (FDA 510(k) Clearance)

Class I Radiology device.

K944445 · Med Corp. · Radiology device
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May 1995
Decision
241d
Days
Class 1
Risk

K944445 is an FDA 510(k) clearance for the ED CORP RADIATION SCREEN. Classified as Screen, Leaded, Operator Radiation Protector (product code EAK), Class I - General Controls.

Submitted by Med Corp. (Ames, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 241 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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 Med Corp. devices

Submission Details

510(k) Number K944445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date May 11, 1995
Days to Decision 241 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
134d slower than avg
Panel avg: 107d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAK Screen, Leaded, Operator Radiation Protector
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.