Cleared Traditional

K902989 - G.E. MONITROL 90 AND G.E. MONITROL 15 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K902989 · Electromek Diagnostic Systems, Inc. · Radiology device
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Oct 1990
Decision
125d
Days
Class 2
Risk

K902989 is an FDA 510(k) clearance for the G.E. MONITROL 90 AND G.E. MONITROL 15. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Electromek Diagnostic Systems, Inc. (Troy, US). The FDA issued a Cleared decision on October 29, 1990 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 K902989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1990
Decision Date October 29, 1990
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.