Cleared Traditional

K012373 - LIFERAY WL CASSETTE, LIFERAY KW CASSETTE

K012373 is an FDA 510(k) clearance for LIFERAY WL CASSETTE, manufactured by Ferrania S.P.A.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K012373 · Ferrania S.P.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
14d
Days
Class 2
Risk

K012373 is an FDA 510(k) clearance for the LIFERAY WL CASSETTE, LIFERAY KW CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Ferrania S.P.A. (Ferrania, Savona, IT). The FDA issued a Cleared decision on August 9, 2001 after a review of 14 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 - K012373

510(k) Number K012373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date August 09, 2001
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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.
GEORGE KREINER

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 K012373.
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 FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · Ferrania USA, Inc. · Oct 2001
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
K983918 · Mastek, Inc. · Mar 1999
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · Imation Corp. · Mar 1998
CM & CM DS-7
K963914 · Konica Medical Corp. · Oct 1997
K012373 · LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
Download PDF FDA Summary Ferrania S.P.A.