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510(k) Data Aggregation

    K Number
    K153205
    Device Name
    IDSS ForceTriad Control Module
    Manufacturer
    BLACK DIAMOND VIDEO, INC
    Date Cleared
    2016-08-01

    (271 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACK DIAMOND VIDEO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
    Device Description
    The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.
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    K Number
    K133413
    Device Name
    IDSS SLC
    Manufacturer
    BLACK DIAMOND VIDEO
    Date Cleared
    2014-01-07

    (61 days)

    Product Code
    FTA
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACK DIAMOND VIDEO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
    Device Description
    IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.
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