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510(k) Data Aggregation

    K Number
    K063424
    Device Name
    FILM DIGITZER, MODEL 2908 MAMMO PRO
    Manufacturer
    ARRAY CORP.
    Date Cleared
    2006-12-21

    (38 days)

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

    ARRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images. The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis. The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.
    Device Description
    Film Digitizer, Model 2908 Mammo Pro
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    K Number
    K033637
    Device Name
    MEDICAL IMAGE DIGITIZER, MODEL 2908
    Manufacturer
    ARRAY CORP.
    Date Cleared
    2003-12-17

    (28 days)

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

    ARRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.
    Device Description
    Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.
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    K Number
    K982785
    Device Name
    FILM DIGITIZER MODEL 2905
    Manufacturer
    ARRAY CORP.
    Date Cleared
    1998-10-15

    (69 days)

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

    ARRAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.
    Device Description
    The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features: - (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0. - 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density. - 3) The 2905 can read a film at high speed using laser. - 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.
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