Cleared Traditional

K922483 - DU PONT COMPACT DAYLIGHT SYSTEM 2000

K922483 is the FDA 510(k) clearance for DU PONT COMPACT DAYLIGHT SYSTEM 2000 by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Radiology device (product code KPX) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K922483 · E.I. Dupont DE Nemours & Co., Inc. · Radiology device
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Sep 1992
Decision
107d
Days
Class 2
Risk

K922483 is an FDA 510(k) clearance for the DU PONT COMPACT DAYLIGHT SYSTEM 2000. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K922483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 11, 1992
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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 - KPX Changer, Radiographic Film/cassette

All 8
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K922483.
TRANS X-1000
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K925169 · Shimadzu Medical Systems · Dec 1992
ADDITIONAL MODEL TO CANON UNIVERSAL STAND
K870048 · Canon USA, Inc. · Jan 1987
UNIVERSAL STAND FOR FILM CHANGER
K862575 · Canon USA, Inc. · Jul 1986
UNIVERSAL STAND FOR FILM CHANGER
K853928 · Canon USA, Inc. · Oct 1985