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510(k) Data Aggregation

    K Number
    K092581
    Device Name
    MITS DICOM GATEWAY AND IMAGE MANAGER
    Date Cleared
    2009-10-30

    (70 days)

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

    MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MITS DICOM Gateway and Image Manager is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources ( i.e. ultrasound system, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
    Device Description
    MITS DICOM Gateway and Image Manager is a suite of applications designed and produced by MITSMED Medical Instrument Technology CO., Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The DICOM converter application is MITS DICOM Gateway. The server side is MITS Image Manager SERVER. And the client side is MITS Image Manager CLIENT.
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