Cleared Traditional

K896665 - EXT-600 TABLE, RADIOGRAPHIC, ELEVATING

K896665 is an FDA 510(k) clearance for EXT-600 TABLE, manufactured by Rms Div.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K896665 · Rms Div. · Radiology device
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Jan 1990
Decision
56d
Days
Class 2
Risk

K896665 is an FDA 510(k) clearance for the EXT-600 TABLE, RADIOGRAPHIC, ELEVATING. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Rms Div. (Addison, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 56 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 - K896665

510(k) Number K896665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date January 22, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
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 28
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K896665.
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111
K912516 · Continental X-Ray Corp. · Nov 1991
CLASSIC 4-WAY ELEVATING TABLE
K912474 · Continental X-Ray Corp. · Sep 1991
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
K903921 · Imt America, Inc. · Dec 1990
GX-ELEVATOR
K894188 · Gendex Corp. · Oct 1989
HUGH YOUNG II UROLOGICAL TABLE
K891403 · Mallinckrodt Group, Inc. · Jun 1989
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · Warner-Lambert Co. · Jun 1989
K896665 · EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
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