Cleared Traditional

K944445 - ED CORP RADIATION SCREEN

K944445 is an FDA 510(k) clearance for ED CORP RADIATION SCREEN, manufactured by Med Corp.. The device is a Class 1 Radiology device with product code EAK cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K944445 · Med Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944445

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.

EAK Device Classification - Class 1, General Controls

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.