Cleared Traditional

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

K954294 is an FDA 510(k) clearance for HIGH TRANSMISSION CELLULAR (HTC) GRIDS ..., manufactured by Thermotrex Corp.. The device is a Class 1 Radiology device with product code IXJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

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

FDA 510(k) Submission Details - K954294

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

IXJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - IXJ Grid, Radiographic

Devices cleared under the same product code (IXJ) and FDA review panel - the closest regulatory comparables to K954294.
MITAYA ALUMINUM INTERSPACED X-RAY GRID
K964025 · X-Ray Accessory Corp. · Jun 1997
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K963893 · Smit Rontgen · Nov 1996
RADIOGRAPHIC GRID
K962338 · Unidex Group, Inc. · Jul 1996
KODAK EKTASCAN SP CASSETTE
K925997 · Eastman Kodak Company · Dec 1992
AOR X-RAY ALIGMENT PAD
K837776 · Zimmer, Inc. · Aug 1983