Cleared Traditional

K941475 - CRONEX REGULAR CASSETTE

K941475 is an FDA 510(k) clearance for CRONEX REGULAR CASSETTE, manufactured by Dupont Medical Products. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K941475 · Dupont Medical Products · Radiology device
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Jul 1994
Decision
114d
Days
Class 2
Risk

K941475 is an FDA 510(k) clearance for the CRONEX REGULAR CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 114 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K941475

510(k) Number K941475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date July 20, 1994
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
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 27
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K941475.
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc. · Sep 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
DUPONT CRONEX PORTABLE GRID CASSETTE
K941518 · Dupont Medical Products · Jun 1994
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
K935397 · Victoreen, Inc. · Dec 1993
FUJIFILM EC-B SERIES CASETTE
K932565 · Fujifilm Medical System U.S.A., Inc. · Jul 1993