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    K Number
    K102791
    Device Name
    EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
    Manufacturer
    IMAGE STREAM MEDICAL, INC.
    Date Cleared
    2010-11-23

    (57 days)

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

    IMAGE STREAM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface.
    Device Description
    The EasySuite™ Surgical Light Control (ESLC) is an optional function in the EasySuite™, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room for management of audio systems, and for control of devices such as room lights. The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.
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    K Number
    K081698
    Device Name
    MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
    Manufacturer
    IMAGE STREAM MEDICAL, INC.
    Date Cleared
    2008-07-30

    (43 days)

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

    IMAGE STREAM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control. MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)
    Device Description
    The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights. The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.
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