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510(k) Data Aggregation

    K Number
    K013395
    Device Name
    LIFEJET VIDEO LINK
    Manufacturer
    FERRANIA S.P.A.
    Date Cleared
    2001-10-30

    (15 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRANIA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal. The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.
    Device Description
    The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.
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    K Number
    K012373
    Device Name
    LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
    Manufacturer
    FERRANIA S.P.A.
    Date Cleared
    2001-08-09

    (14 days)

    Product Code
    IXA
    Regulation Number
    892.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRANIA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.
    Device Description
    Ferrania LifeRay™ Cassettes are intended for use during diagnostic x-ray 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 in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless. Radiographic cassettes 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, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.
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    K Number
    K011617
    Device Name
    LIFEJET PRINTER 400
    Manufacturer
    FERRANIA S.P.A. STABILIMENTO DI FERRANIA
    Date Cleared
    2001-06-08

    (14 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERRANIA S.P.A. STABILIMENTO DI FERRANIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.
    Device Description
    The LifeJet™ Printer 400 is an inkjet printer designed to produce high quality color and gray-scale referral medical images. Together with specifically designed medical paper and inks (LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges) the LifeJet™ Printer 400 forms the LifeJet™ 400 System, which is an innovative, convenient and work-flow improving medical printing platform, based on the state of the art inkjet technology, capable of delivering superior and reliable printed images for any medical documentation requirement.
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