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
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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.

View all Ferrania S.P.A. devices

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
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 Peers - IXA Cassette, Radiographic Film

All 35
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K012373.
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