Cleared Traditional

K954294 - HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (FDA 510(k) Clearance)

Class I Radiology device.

K954294 · Thermotrex Corp. · Radiology device
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Feb 1996
Decision
141d
Days
Class 1
Risk

K954294 is an FDA 510(k) clearance for the HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES. Classified as Grid, Radiographic (product code IXJ), Class I - General Controls.

Submitted by Thermotrex Corp. (Danbury, US). The FDA issued a Cleared decision on February 2, 1996 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1910 - 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 Thermotrex Corp. devices

Submission Details

510(k) Number K954294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date February 02, 1996
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXJ Grid, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.