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510(k) Data Aggregation

    K Number
    K201162
    Device Name
    Essence 55SP Large Monitor System
    Manufacturer
    Shenyang Torch-Bigtide Digital Technology Co., Ltd.
    Date Cleared
    2020-08-27

    (119 days)

    Product Code
    DXJ
    Regulation Number
    870.2450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenyang Torch-Bigtide Digital Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Essence 55SP Large Monitor System (Essence 55SP) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.
    Device Description
    The Essence 55SP Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. The system consists of a 55" TFT color LCD Monitor, and optionally a video wall controller, optical graphic extension module, a common PC, and cables.
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    K Number
    K172969
    Device Name
    Essence 55S Large Monitor System
    Manufacturer
    Shenyang Torch-Bigtide Digital Technology Co., Ltd.
    Date Cleared
    2018-01-26

    (122 days)

    Product Code
    DXJ
    Regulation Number
    870.2450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenyang Torch-Bigtide Digital Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Essence 55S Large Monitor System (Essence 55S) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.
    Device Description
    The Essence 55S Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. Thanks to the advantages of the large widescreen monitor, the data can be collected from the video sources using the optional video wall controller AVS-540 and fed into the large display via the DVI lines and / or DP. The optical graphic extension module M1-201SA-TR can be used to convert / transmit the video signal, and the common PC can be taken as a video device.
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