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510(k) Data Aggregation

    K Number
    K083555
    Device Name
    PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
    Manufacturer
    Date Cleared
    2008-12-16

    (14 days)

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

    EMSOMA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PetaVision is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to Image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic applications.
    Device Description
    PetaVision™ is PACS (Picture Archiving and Communication System) software for radlologist and physician doctor. By use of PetaVision™ enables images such as xray and scans to be stored electronically and viewed on screens. Doctors and other health professional can access and compare images at the touch of a button Also, PetaVision™ is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices.
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