Cleared Traditional

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (K040378) - FDA 510(k) Clearance

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

K040378 · Eastman Kodak Company · Radiology device
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May 2004
Decision
97d
Days
Class 2
Risk

K040378 is an FDA 510(k) clearance for the KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253. 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 May 24, 2004 after a review of 97 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

Submission Details

510(k) Number K040378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date May 24, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
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 K040378.
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · Eastman Kodak Company · Jul 2002
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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
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993