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510(k) Data Aggregation

    K Number
    K162885
    Device Name
    SPY Phi Open Field Handheld Fluorescence Imaging System
    Manufacturer
    NOVADAQ TECHNOLOGIES INC.
    Date Cleared
    2017-01-11

    (86 days)

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

    NOVADAQ TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.
    Device Description
    The SPY PHI HH9000 is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgeries. The SPY PHI HH9000 consists of the following components: an Open Field Handheld Imaging Head (HH9030), Light Guide (PC9004), and the Video Processor/Illuminator (VPI) (PC9001). Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging. A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of SPY PHI are possible through switches at either the Imaging Head or the VPI.
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    K Number
    K161792
    Device Name
    PINPOINT Endoscopic Fluorescence Imaging System
    Manufacturer
    Novadaq Technologies Inc.
    Date Cleared
    2016-09-20

    (82 days)

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

    Novadaq Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
    Device Description
    The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System. During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein. To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor. When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.
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