Cleared Traditional

KODAK X-OMAT 460 RA PROCESSOR (K902732) - FDA 510(k) Clearance

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

K902732 · Eastman Kodak Company · Radiology device
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Aug 1990
Decision
57d
Days
Class 2
Risk

K902732 is an FDA 510(k) clearance for the KODAK X-OMAT 460 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 August 17, 1990 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K902732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date August 17, 1990
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K902732.
KODAK M35-MX-0MAT PROCESSOR
K911714 · Eastman Kodak Company · Jun 1991
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K904238 · Eastman Kodak Company · Oct 1990
KODAK M35A-M X-OMAT PROCESSOR
K901772 · Eastman Kodak Company · Jul 1990
KODAK MULTILOADER 700
K885207 · Eastman Kodak Company · Mar 1989
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8
K882320 · Eastman Kodak Company · Jun 1988