Cleared Traditional

K902989 - G.E. MONITROL 90 AND G.E. MONITROL 15

K902989 is an FDA 510(k) clearance for G.E. MONITROL 90 AND G.E. MONITROL 15, manufactured by Electromek Diagnostic Systems, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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

FDA 510(k) Submission Details - K902989

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.

IXR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IXR Table, Radiographic, Tilting

All 49
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K902989.
ELITE 5000
K905501 · Fischer Imaging Corp. · Jan 1991
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K905152 · Shimadzu Medical Systems · Dec 1990
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · Shimadzu Medical Systems · Dec 1990
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
K892226 · Tecnomed, Inc. · Apr 1989
GENESIS 180
K883863 · Fischer Imaging Corp. · Oct 1988