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Liferay Fw Mammo Cassette, Liferay Kw Mammo Casette

by Ferrania USA, Inc.

510(k) K013229

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013229 Date12 Oct 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IXA
Device Class
Class II
Regulation
21 CFR Part 892.1850
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Liferay Fw Mammo Cassette and Liferay Kw Mammo Casette are radiographic film cassettes used in mammography, functioning as light-proof enclosures for X-ray film and maintaining intimate contact between film and X-ray intensifying screen during exposure. The cassettes are designed for use in radiology. The Kw model includes a window compatible with Kodak ID printers, while the Fw model includes a window compatible with Ferrania ID printers for patient identification.

The cassettes are supplied with FDA 510K authorizations, specifically cleared under K-number K013229 in 2001. They are classified as Class II medical devices, with a product code of IXA. The devices are used in mammography applications, and their regulatory status is documented under the provided K-number and product code.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Liferay Mammo Cassettes used for?

    Liferay Mammo Cassettes are used in mammography applications as light-proof enclosures for X-ray film, maintaining intimate contact between film and X-ray intensifying screen during exposure.

  • What is the difference between the Fw and Kw models?

    The Kw model includes a window compatible with Kodak ID printers, while the Fw model includes a window compatible with Ferrania ID printers for patient identification.

  • Are the cassettes supplied sterile?

    The device data does not specify if the cassettes are supplied sterile, but they are designed for use in radiology and are classified as Class II medical devices.

  • What is the regulatory status of the Liferay Mammo Cassettes?

    The cassettes are cleared under FDA 510K authorizations, specifically under K-number K013229, and are classified as Class II medical devices with a product code of IXA.