Cleared Traditional

MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE (K903921) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 7
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K903921.
ANGIOREX CAT-350B
K951053 · Toshiba America Medical Systems, In.C · Apr 1995
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE
K943926 · Philips Medical Systems (Cleveland), Inc. · Nov 1994
CAT-250B
K915413 · Toshiba America Medical Systems, In.C · Dec 1991
COMPAX MODEL 40, 400, 400T
K884930 · General Electric Co. · Dec 1988
VRT TABLE
K827928 · General Electric Co. · Sep 1982
RX PEDESTAL TABLE
K772283 · General Electric Co. · Dec 1977