Cleared Traditional

K926407 - MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM

K926407 is an FDA 510(k) clearance for MODEL COLE TAB-2 TABLE W/MODEL COLE SFD..., manufactured by Nucletron-Oldelft Corp.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K926407 · Nucletron-Oldelft Corp. · Radiology device
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Mar 1993
Decision
100d
Days
Class 2
Risk

K926407 is an FDA 510(k) clearance for the MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Nucletron-Oldelft Corp. (Urbanna, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 100 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 Nucletron-Oldelft Corp. devices

FDA 510(k) Submission Details - K926407

510(k) Number K926407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date March 31, 1993
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXJ Device Classification - Class 2, Special Controls

Product Code KXJ Table, Radiologic
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 - KXJ Table, Radiologic

All 18
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K926407.
CARBON FIBER COUCH INSERT
K950068 · Medtec, Inc. · Apr 1995
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · Philips Medical Systems North America, Inc. · Mar 1994
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES
K931724 · Continental X-Ray Corp. · Jun 1993
CAG-02A
K922098 · Toshiba America Medical Systems, In.C · Jul 1992
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400
K913121 · Continental X-Ray Corp. · Aug 1991
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
K874639 · Shimadzu Precision Instruments, Inc. · Dec 1987