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510(k) Data Aggregation

    K Number
    K081215
    Device Name
    VOLUMINA
    Manufacturer
    Date Cleared
    2008-08-26

    (118 days)

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

    KJAYA MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.
    Device Description
    Volumina is a Class II software application comprised of a client module and a server module. Volumina is intended to provide a diagnostic quality image to a qualified health care professional to visualize multimodal medical image data.
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