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510(k) Data Aggregation
K Number
K013229Device Name
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
Manufacturer
FERRANIA USA, INC.
Date Cleared
2001-10-12
(15 days)
Product Code
IXA
Regulation Number
892.1850Why did this record match?
Applicant Name (Manufacturer) :
FERRANIA USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film.
Device Description
Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film. The Cassettes are available in two sizes and two models. The LifeRay™ KW Mammo Cassettes contain a window that is compatible with Kodak ID Printers for marking film with patient identification data. The LifeRay™ FW Mammo Cassettes contain a window that is compatible with Ferrania ID Printers for the same purpose as before.
Both Ferrania LifeRay™ Mammo Cassettes and the predicate device are composed of:
- a light tight chamber for preventing radiographic film exposure,
- a compressible backplate material to assure intimate film-screen contact,
- a latching mechanism for removal and replacement of radiographic film.
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