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510(k) Data Aggregation

    K Number
    K030363
    Device Name
    ORG@NIZER, MODEL VERSION 3.0
    Date Cleared
    2003-03-27

    (51 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EBIT SANITA, S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform. This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value: ®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting; @Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.
    Device Description
    The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.
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