Clearance Summary
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE received FDA 510(k) clearance under submission number K013229, sponsored by Ferrania USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-10-12.
- Submission: K013229
- Applicant / Sponsor: Ferrania USA, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1850
- Decision date: 2001-10-12
Classification & Regulation
This clearance is catalogued under FDA product code IXA and 21 CFR 892.1850, within the Radiology review panel as a Class II device.