Cleared Traditional

K921316 - MG-1001 TUBE HOUSING ASSEMBLY (FDA 510(k) Clearance)

Class I Radiology device.

K921316 · Magma Corp. · Radiology device
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Jun 1992
Decision
97d
Days
Class 1
Risk

K921316 is an FDA 510(k) clearance for the MG-1001 TUBE HOUSING ASSEMBLY. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Magma Corp. (Teaneck, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1760 - 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 K921316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date June 22, 1992
Days to Decision 97 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
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITY Assembly, Tube Housing, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1760
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.