Cleared Traditional

K914143 - KODAK X-OMAT 480 RA PROCESSOR

K914143 is an FDA 510(k) clearance for KODAK X-OMAT 480 RA PROCESSOR, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K914143 · Eastman Kodak Company · Radiology device
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Jan 1992
Decision
112d
Days
Class 2
Risk

K914143 is an FDA 510(k) clearance for the KODAK X-OMAT 480 RA PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 6, 1992 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K914143

510(k) Number K914143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date January 06, 1992
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 50
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K914143.
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