Cleared Traditional

K971431 - UMI X-RAY FILM CASSETTE

K971431 is an FDA 510(k) clearance for UMI X-RAY FILM CASSETTE, manufactured by Umi Intl.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K971431 · Umi Intl. · Radiology device
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May 1997
Decision
33d
Days
Class 2
Risk

K971431 is an FDA 510(k) clearance for the UMI X-RAY FILM CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Umi Intl. (Bedford, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 33 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 Umi Intl. devices

FDA 510(k) Submission Details - K971431

510(k) Number K971431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1997
Decision Date May 20, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXA Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K971431.
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
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KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
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KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · Eastman Kodak Company · Dec 2001
SOLO-SLED
K970090 · Solo-Sled, LLC · Apr 1997
KODAK MN-R 2000 CASSETTE
K961453 · Eastman Kodak Company · Jul 1996
CRONEX RADIATION THERAPY CASSETTE
K953724 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995