Cleared Traditional

K923334 - MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER

K923334 is an FDA 510(k) clearance for MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER, manufactured by Cook, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K923334 · Cook, Inc. · Radiology device
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Jan 1993
Decision
203d
Days
Class 2
Risk

K923334 is an FDA 510(k) clearance for the MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Cook, Inc. (Ontario L4a 7x5, CA). The FDA issued a Cleared decision on January 26, 1993 after a review of 203 days - an extended review 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: 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 Cook, Inc. devices

FDA 510(k) Submission Details - K923334

510(k) Number K923334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date January 26, 1993
Days to Decision 203 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
96d slower than avg
Panel avg: 107d · This submission: 203d
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 K923334.
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
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
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