Cleared Traditional

K961453 - KODAK MN-R 2000 CASSETTE

K961453 is an FDA 510(k) clearance for KODAK MN-R 2000 CASSETTE, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K961453 · Eastman Kodak Company · Radiology device
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Jul 1996
Decision
100d
Days
Class 2
Risk

K961453 is an FDA 510(k) clearance for the KODAK MN-R 2000 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 July 25, 1996 after a review of 100 days - within the typical 510(k) review window.

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: 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 - K961453

510(k) Number K961453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1996
Decision Date July 25, 1996
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 34
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K961453.
CM & CM DS-7
K963914 · Konica Medical Corp. · Oct 1997
UMI X-RAY FILM CASSETTE
K971431 · Umi Intl. · May 1997
SOLO-SLED
K970090 · Solo-Sled, LLC · Apr 1997
RADIOGRAPHIC FILM CASSETTES
K962336 · Unidex Group, Inc. · Jul 1996
CRONEX RADIATION THERAPY CASSETTE
K953724 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995