Cleared Traditional

K903921 - MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE

K903921 is an FDA 510(k) clearance for MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING..., manufactured by Imt America, Inc.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K903921 · Imt America, Inc. · Radiology device
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Dec 1990
Decision
102d
Days
Class 2
Risk

K903921 is an FDA 510(k) clearance for the MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Imt America, Inc. (Charlotte, US). The FDA issued a Cleared decision on December 4, 1990 after a review of 102 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 Imt America, Inc. devices

FDA 510(k) Submission Details - K903921

510(k) Number K903921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1990
Decision Date December 04, 1990
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
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 K903921.
CAT-250B
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