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510(k) Data Aggregation

    K Number
    K112570
    Device Name
    CENTRICITY CARDIO IMAGING
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Date Cleared
    2011-11-30

    (85 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
    Device Description
    Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices. Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols. Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.
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    K Number
    K970116
    Device Name
    ESG-1 ELECTROSONOGRAM (ESG-1)
    Manufacturer
    MYO-TRONICS, INC.
    Date Cleared
    1997-04-02

    (79 days)

    Product Code
    NFQ
    Regulation Number
    872.2050
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    Matched: '872.2050'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
    Device Description
    ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
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