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510(k) Data Aggregation

    K Number
    K222890
    Device Name
    RADIANCE ULTRA 32 4K ZEROWIRE DUO
    Manufacturer
    NDS Surgical Imaging, LLC.
    Date Cleared
    2022-10-19

    (26 days)

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

    NDS Surgical Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiance Ultra 32" 4K ZeroWire Duo is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radiofrequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.
    Device Description
    Radiance Ultra 32" 4K ZeroWire Duo is a medical LCD display designed to both wirelessly receive or transmit video signal with up to 4K resolution over a radio frequency link to a partner display.
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    K Number
    K170598
    Device Name
    ZeroWire Mobile
    Manufacturer
    NDS Surgical Imaging, LLC.
    Date Cleared
    2017-04-07

    (37 days)

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

    NDS Surgical Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures. The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.
    Device Description
    ZeroWire Mobile is a medical grade, battery powered pole stand that eliminates the need for a power cord. It will be used as an accessory, secondary monitor display in Endo/GI procedure rooms, surgical operating rooms, or other clinical settings. ZeroWire Mobile is a cordless stand with a wireless monitor solution that provides the procedure or operating room with a mobile second display monitor eliminating the risk of biohazard contamination of cords and cables, and cable/cord trip hazards. The ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228). The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or < 33 lbs in weight, with 2 mounted power modules as DC power supply source for the monitor. The system is completed with a 4-bay wall-mount charger, allowing to charge 4 power modules simultaneously. Three keys elements of the ZeroWire Mobile stand are the mechanical stand it-self, the DC -DC converter plus battery hot-swap monitoring circuitry, and the firmware allowing the user to interface and monitor the battery status. Since the power module supply output can vary from 20V to 25V and a 24V +/- 5% output is required to power the monitor, there is a need for a DC-DC converter to regulate the DC output voltage. The system can run with either one or both power modules mounted and replacement of the drained power module shall not affect the voltage output of the running power module.
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    K Number
    K161228
    Device Name
    Radiance Ultra Series ZeroWire Embedded
    Manufacturer
    NDS SURGICAL IMAGING, LLC.
    Date Cleared
    2016-05-26

    (24 days)

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

    NDS SURGICAL IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field
    Device Description
    Radiance Ultra series ZeroWire Embedded monitors are designed with an integrated wireless video receiver module (Rx), enabling the reception of a video signal over a radio frequency link instead of a video cable. These monitors are designed for use in non-sterile healthcare environments. The Radiance Ultra series ZeroWire Embedded is a medical grade wireless video streaming device pair. The external transmitter (Tx) unit is designed to be mounted on a primary display, on an endoscopic cart, or any other elevated location in close vicinity to the video source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.
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    K Number
    K151609
    Device Name
    ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
    Manufacturer
    NDS SURGICAL IMAGING LLC
    Date Cleared
    2015-11-06

    (144 days)

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

    NDS SURGICAL IMAGING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDS ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.
    Device Description
    Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and EndoVue devices.
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    K Number
    K133609
    Device Name
    THE DOME S6C
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2014-02-28

    (95 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. Model Dome S6c is not intended for mammography use.
    Device Description
    The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities.
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    K Number
    K132770
    Device Name
    DOME S10
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2014-01-30

    (148 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.
    Device Description
    The Dome S10 is a widescreen 30-inch 10 megapixel grayscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.
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    K Number
    K131115
    Device Name
    ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2013-06-07

    (49 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
    Device Description
    Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and Endo Vue devices. The device can operate on up to 9 channels.
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    K Number
    K120709
    Device Name
    THE DOME GX4MP COLOR NONITOR
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2012-04-06

    (29 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dome® GX4MP Color Monitor is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
    Device Description
    The Dome® GX4MP Color Monitor is a 30-inch 4 megapixel Color flat-panel AMLCD-TFT monitor for use with IBM PC or PC compatible computers for widescreen imaging. The combination of high resolution and high contrast ratio allow the viewing of color and grayscale images simultaneously. Bezel-free framing of 4 megapixels of data is presented in a landscape resolution of 2560 x 1600 pixels. Gamma correction is achieved on this true color display from a palette of 1,786 near-gray values. The integrated Dome RightLight Controller monitors and stabilizes backlight luminance. The display unit includes a PCI Express graphics board to support the required duallink connectivity for the display.
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    K Number
    K100195
    Device Name
    NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2010-04-21

    (89 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
    Device Description
    The ZeroWire® wireless device is a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to a video display such as Radiance and EndoVue LCD surgical monitors.
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    K Number
    K080320
    Device Name
    PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2008-02-21

    (15 days)

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

    NDS SURGICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.
    Device Description
    The PrimeVue 21 inch 3MP Color Display is a diagnostic display. The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
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