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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CHANTEL CARSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IXA Cassette, Radiographic Film

All 49
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
K023020 · Agfa Corp. · Sep 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · Eastman Kodak Company · Jul 2002
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · Eastman Kodak Company · Dec 2001
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K012373 · Ferrania S.P.A. · Aug 2001
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K983918 · Mastek, Inc. · Mar 1999
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · Imation Corp. · Mar 1998
K013229 · LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
Download PDF FDA Summary Ferrania USA, Inc.