Cleared Traditional

K900620 - DU PONT MAMMOGRAPHY CASSETTE

K900620 is the FDA 510(k) clearance for DU PONT MAMMOGRAPHY CASSETTE by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Radiology device (product code IXA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K900620 · E.I. Dupont DE Nemours & Co., Inc. · Radiology device
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Feb 1990
Decision
18d
Days
Class 2
Risk

K900620 is an FDA 510(k) clearance for the DU PONT MAMMOGRAPHY CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K900620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date February 26, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
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 23
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K900620.
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · Cook, Inc. · Jan 1993
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK X-OMATIC RA CASSETTE
K890750 · Eastman Kodak Company · Mar 1989
KODAK MIN-R 2 CASSETTE
K890361 · Eastman Kodak Company · Feb 1989