Cleared Traditional

K902986 - G.E. DXD 325/350/350II/DXD 525/525II GENERATORS

K902986 is an FDA 510(k) clearance for G.E. DXD 325/350/350II/DXD 525/525II GE..., manufactured by Electromek Diagnostic Systems, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 232-day FDA review.

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

FDA 510(k) Submission Details - K902986

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.

IZO Device Classification - Class 1, General Controls

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.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K902986.
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