Cleared Traditional

K893703 - AFTER LOADING DEVICE KIT (FDA 510(k) Clearance)

Class I Radiology device.

K893703 · Medical Radiation Devices, Inc. · Radiology device
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Sep 1989
Decision
123d
Days
Class 1
Risk

K893703 is an FDA 510(k) clearance for the AFTER LOADING DEVICE KIT. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Medical Radiation Devices, Inc. (Dothan, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Medical Radiation Devices, Inc. devices

Submission Details

510(k) Number K893703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date September 18, 1989
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
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.