Cleared Traditional

K926407 - MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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.