Cleared Traditional

K924444 - B-4 FOUR-WAY RADIOGRAPHIC TABLE

K924444 is an FDA 510(k) clearance for B-4 FOUR-WAY RADIOGRAPHIC TABLE, manufactured by Control-X, Inc.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K924444 · Control-X, Inc. · Radiology device
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Feb 1993
Decision
157d
Days
Class 2
Risk

K924444 is an FDA 510(k) clearance for the B-4 FOUR-WAY RADIOGRAPHIC TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 157 days - an extended review 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: 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 Control-X, Inc. devices

FDA 510(k) Submission Details - K924444

510(k) Number K924444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date February 05, 1993
Days to Decision 157 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 107d · This submission: 157d
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 K924444.
CATHETERIZATION TABLE KS-60
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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
SHIMADZU RADIOGRAPHIC TABLE BK-100
K925174 · Shimadzu Medical Systems · Nov 1992
DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004
K921501 · Biodan Medical Systems, Ltd. · May 1992
CATHERIZATION KS-50
K920732 · Shimadzu Medical Systems · Apr 1992