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510(k) Data Aggregation

    K Number
    K011949
    Device Name
    ELK LASER IMAGER, MODEL EL-DRY 4000
    Date Cleared
    2001-08-29

    (69 days)

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

    NISHIMOTO SANGYO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EL-DRY 4000 digitizes image data output from medical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.
    Device Description
    The EL-DRY 4000 is a desk top radiographic Laser Imager. The EL-DRY 4000 The EL-DN I - 1000 10 a deen top edical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. Digitized image data is processed to match the film size mcall of semiconductor laser 22gitLed . and formats (1,2,4,6,9,12,15,16, 20, 24), and these processed data converted into laser out put. Three different image-processing methods are available; selection is made via the imaging pad. This system is controlled by a micro-processor, and all parameters can be set using the imaging pad. Furthermore, necessary information such as format, system status, and error indicators are all shown on an LCD readout. In addition, 15 types of LUT (characteristic of film density levels) settings are available; selection is also made using the imaging pad. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.
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    K Number
    K984409
    Device Name
    ELK LASER FILM DIGITIZER
    Date Cleared
    1999-02-12

    (65 days)

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

    NISHIMOTO SANGYO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the ED-3000 is to produce digital copies of radiological film. The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.
    Device Description
    The ED-3000 is a desk top radiographic film digitizer incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthagonal direction, a light collector and photomutiplier and electronic circuitry for analog-to-digital conversion, system operation and connection to external networks.
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