Cleared Traditional

K894188 - GX-ELEVATOR

K894188 is an FDA 510(k) clearance for GX-ELEVATOR, manufactured by Gendex Corp.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K894188 · Gendex Corp. · Radiology device
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Oct 1989
Decision
109d
Days
Class 2
Risk

K894188 is an FDA 510(k) clearance for the GX-ELEVATOR. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Gendex Corp. (Franklin Park, US). The FDA issued a Cleared decision on October 3, 1989 after a review of 109 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 Gendex Corp. devices

FDA 510(k) Submission Details - K894188

510(k) Number K894188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date October 03, 1989
Days to Decision 109 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 20
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K894188.
CAT-250B
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CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111
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CLASSIC 4-WAY ELEVATING TABLE
K912474 · Continental X-Ray Corp. · Sep 1991
HUGH YOUNG II UROLOGICAL TABLE
K891403 · Mallinckrodt Group, Inc. · Jun 1989
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · Warner-Lambert Co. · Jun 1989
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB
K893129 · Continental X-Ray Corp. · Jun 1989