Cleared Traditional

K896324 - ELITE 1500 RADIOGRAPHIC TILTING TABLE

K896324 is an FDA 510(k) clearance for ELITE 1500 RADIOGRAPHIC TILTING TABLE, manufactured by Rms Div.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K896324 · Rms Div. · Radiology device
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Nov 1989
Decision
20d
Days
Class 2
Risk

K896324 is an FDA 510(k) clearance for the ELITE 1500 RADIOGRAPHIC TILTING TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Rms Div. (Addison, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K896324

510(k) Number K896324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date November 21, 1989
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
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 73
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K896324.
UROMAT 2000
K903395 · Pausch Corp. · Aug 1990
F.A.S.T. TABLE
K896583 · Oec-Diasonics, Inc. · Mar 1990
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
K896119 · Rms Div. · Nov 1989
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
K892226 · Tecnomed, Inc. · Apr 1989
BETA 90/50 MOBILE IMAGING TABLE
K884531 · Beta Medical Products Co. · Jan 1989
K896324 · ELITE 1500 RADIOGRAPHIC TILTING TABLE
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