Cleared Traditional

KODAK X-MAT 270 RA PROCESSOR (K904238) - FDA 510(k) Clearance

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

K904238 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
19d
Days
Class 2
Risk

K904238 is an FDA 510(k) clearance for the KODAK X-MAT 270 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 October 3, 1990 after a review of 19 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 K904238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1990
Decision Date October 03, 1990
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
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 K904238.
KODAK 100-J & 100-K CHEMICAL MIXERS
K911713 · Eastman Kodak Company · Jun 1991
KODAK M35-MX-0MAT PROCESSOR
K911714 · Eastman Kodak Company · Jun 1991
KODAK X-OMAT MULTILOADER 300
K905607 · Eastman Kodak Company · Mar 1991
KODAK X-OMAT 460 RA PROCESSOR
K902732 · Eastman Kodak Company · Aug 1990
KODAK M35A-M X-OMAT PROCESSOR
K901772 · Eastman Kodak Company · Jul 1990
KODAK MULTILOADER 700
K885207 · Eastman Kodak Company · Mar 1989