Cleared Traditional

K013229 - LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE

K013229 is an FDA 510(k) clearance for LIFERAY FW MAMMO CASSETTE, manufactured by Ferrania USA, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K013229 · Ferrania USA, Inc. · Radiology device
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Oct 2001
Decision
15d
Days
Class 2
Risk

K013229 is an FDA 510(k) clearance for the LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Ferrania USA, Inc. (Weatherford, US). The FDA issued a Cleared decision on October 12, 2001 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 Ferrania USA, Inc. devices

FDA 510(k) Submission Details - K013229

510(k) Number K013229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date October 12, 2001
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.

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 35
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K013229.
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
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K983918 · Mastek, Inc. · Mar 1999
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · Imation Corp. · Mar 1998
CM & CM DS-7
K963914 · Konica Medical Corp. · Oct 1997