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510(k) Data Aggregation

    K Number
    K162141
    Device Name
    Restore PACS
    Date Cleared
    2016-09-02

    (32 days)

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

    XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.
    Device Description
    Restore PACS include features that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Restore PACS is designed to be deployed over TCP/IP networking infrastructure available in customer sites and utilizes commercially available hardware and operating systems. The system of Restore PACS does not generate any original medical images in the Restore PACS are received from DICOM compliant systems.
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