Liferay WL Cassette, Liferay KW Cassette
510(k) K012373
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012373 | Date9 Aug 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
The Liferay WL Cassette and Liferay KW Cassette are radiographic film cassettes designed to provide a light-proof enclosure for direct exposure of radiographic film during diagnostic X-ray procedures. These devices are intended to hold radiographic film in close contact with an X-ray intensifying screen, ensuring optimal image quality and reducing film fogging. They fall under the classification of Cassette, Radiographic Film and are classified as Class II medical devices.
These cassettes are supplied as reusable devices and are intended for use in radiology settings. They are not sterile and must be cleaned and maintained according to manufacturer guidelines. The devices are regulated under FDA 510(k) clearance (K012373) and comply with regulation 892.1850. They are designed for standard radiographic film sizes and are compatible with X-ray intensifying screens. No specific MRI safety information is provided, and they are not intended for use in MRI environments.
Other devices from Ferrania S.P.A.
Questions
AI-generated answers, 1 Oct 2026
What are the Liferay WL and KW Cassettes designed for?
The Liferay WL and KW Cassettes are designed to provide a light-proof enclosure for direct exposure of radiographic film during diagnostic X-ray procedures. They hold radiographic film in close contact with an X-ray intensifying screen, which helps ensure high-quality images and minimizes film fogging. These cassettes are specifically intended for use in radiology settings.
Are the Liferay WL/KW Cassettes single-use or reusable?
The Liferay WL and KW Cassettes are reusable devices. They are not intended for single-use and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene in radiology environments.
What film sizes are compatible with these cassettes?
The Liferay WL and KW Cassettes are designed for standard radiographic film sizes. While the exact sizes are not specified in the provided data, they are compatible with X-ray intensifying screens commonly used in diagnostic radiology, ensuring versatility for typical clinical applications.
Do these cassettes require sterilization before use?
No, the Liferay WL and KW Cassettes are not sterile. They are intended for reusable applications in radiology settings and must be cleaned and maintained as per the manufacturer’s instructions. Sterilization is not applicable or recommended for these devices.
Are these cassettes safe for use in MRI environments?
No specific MRI safety information is provided for the Liferay WL and KW Cassettes. They are not intended for use in MRI environments, so caution should be exercised when handling them near magnetic fields.