Cleared Traditional

AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE (K023020) - FDA 510(k) Clearance

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

K023020 · Agfa Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
15d
Days
Class 2
Risk

K023020 is an FDA 510(k) clearance for the AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CUR.... Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on September 26, 2002 after a review of 15 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 Agfa Corp. devices

Submission Details

510(k) Number K023020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date September 26, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 20
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K023020.
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
K040378 · Eastman Kodak Company · May 2004
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · Eastman Kodak Company · Jul 2002
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · Eastman Kodak Company · Dec 2001
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