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510(k) Data Aggregation

    K Number
    K132532
    Device Name
    SYNGO.PLAZA VB10A
    Manufacturer
    SIEMENS AG HEALTHCARE
    Date Cleared
    2013-12-09

    (119 days)

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

    SIEMENS AG HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.
    Device Description
    syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting. syngo.plaza is a "software only"-system. which will be delivered on DVD to be installed on common IT hardware, matching the syngo.plaza hardware requirements. syngo.plaza will be installed by Siemens implementation engineers. The integration into customer specific 17 environments is offered based on professional services. Updates / upgrades are offered based on service contracts and fulfilled by trained service technicians.
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