Cleared Traditional

KODAK X-OMATIC RA CASSETTE (K890750) - FDA 510(k) Clearance

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

K890750 · Eastman Kodak Company · Radiology device
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Mar 1989
Decision
16d
Days
Class 2
Risk

K890750 is an FDA 510(k) clearance for the KODAK X-OMATIC RA CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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 K890750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date March 01, 1989
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 19
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K890750.
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992
DU PONT MAMMOGRAPHY CASSETTE
K900620 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK MIN-R 2 CASSETTE
K890361 · Eastman Kodak Company · Feb 1989
KODAFLEX II RADIATION THERAPY L CASSETTE
K885178 · Eastman Kodak Company · Feb 1989
KODAK KODAFLEX II CASSETTE
K875083 · Eastman Kodak Company · Jan 1988