Cleared Traditional

K884340 - AMX-110, AMX-II AND AMX-III (FDA 510(k) Clearance)

Class I Radiology device.

K884340 · Dyna-Med · Radiology device
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Jan 1989
Decision
102d
Days
Class 1
Risk

K884340 is an FDA 510(k) clearance for the AMX-110, AMX-II AND AMX-III. Classified as Accessories, Traction (product code ILZ), Class I - General Controls.

Submitted by Dyna-Med (Victoria, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.5925 - 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.

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Submission Details

510(k) Number K884340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date January 24, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILZ Accessories, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5925
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.