Cleared Traditional

K902986 - G.E. DXD 325/350/350II/DXD 525/525II GENERATORS (FDA 510(k) Clearance)

Class I Radiology device.

K902986 · Electromek Diagnostic Systems, Inc. · Radiology device
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Feb 1991
Decision
232d
Days
Class 1
Risk

K902986 is an FDA 510(k) clearance for the G.E. DXD 325/350/350II/DXD 525/525II GENERATORS. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Electromek Diagnostic Systems, Inc. (Troy, US). The FDA issued a Cleared decision on February 13, 1991 after a review of 232 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Electromek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K902986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1990
Decision Date February 13, 1991
Days to Decision 232 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 107d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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.