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Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic 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, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures. Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts. Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope, Exoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time visible and fluorescence imaging similar to that provided by conventional imaging system used in endoscopic surgery and innovative 3D visible and fluorescence imaging in endoscopic surgery. Besides, Stellar Imaging System is also used to provide real-time fluorescence confirmation in open field. The Stellar Imaging System including the laparoscope and the exoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using a camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc. The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

The Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.

Insufflator (OPTO-IFL1000) is a CO2 insufflation device for creating and maintaining a pneumoperitoneum during laparoscopic examinations and operations. It is capable of establishing the surgical field of view and operating space. CO2 gas can be injected into abdominal cavity by the device, and the gas separates the abdominal wall from the internal organs of the abdominal cavity, forming a space for the operation and visual field. The device is to be used with the following insufflation tubes: - 1. OPTO-T1000H (with heating function) - 2. OPTO-T1000 (without heating function)

Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography. The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures. Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The FloNavi Open Field Fluorescence Imaging System is an imaging system used in hospitals for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation for use in imaging during various surgical procedures. The FloNavi Open Field Fluorescence Imaging System has two system models: HD system and 4K system. Each system consists of the following main components: Imaging Head, Image Processing Unit, power supply cord and video cables. 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 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. The cameras in the Imaging Head capture the fluorescent image under near infrared illumination or a color image under white light illumination. The Image Processing Unit 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 the FloNavi Open Field Fluorescence Imaging System are possible through switches at either the Imaging Head or the Image Processing Unit. The FloNavi Open Field Fluorescence Imaging System is a reusable device and provided nonsterile. Its components should be cleaned and low-level disinfected prior to the first use and after every subsequent use.

The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.

The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°).

Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic 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, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The proposed system, FloNavi Endoscopic Fluorescence Imaging System (FloNavi System) is comprised of an image processing unit, a camera head, and a light source (including a flexible light guide cable). There are two models of the proposed system. The primary components of each model are provided in Table 1. Model 1: Image Processing Unit: OPTO-CAM214K, Camera Head: OPTO-CHD214KE/OPTO-CHD214KH, Light Source: OPTO-LED214K Model 2: Image Processing Unit: OPTO-CAM2100, Camera Head: OPTO-CHD2100, Light Source: OPTO-LED2100 FloNavi Endoscopic Fluorescence Imaging System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging. During surgical procedures, FloNavi 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 light source and the resulting reflecting 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, FloNavi is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the light source, and the fluorescence response is then imaged with the camera, processed and displayed on a video monitor. The proposed system is designed to be used with rigid endoscopes, monitors and other ancillary equipment.

Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures. Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.

The Endoscopic Camera System comprises the Image Processing Unit, the Camera Head (including the objective lens), power supply cord and video cables. The Camera Head with integrated cable can be connected to the Image Processing Unit through the LEMO interface. During surgical procedures, the Endoscopic Camera System is used to provide real-time visible imaging similar to that provided by conventional imaging system used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflected light is collected by a variety of laparoscopes that are attached to the camera head via equipment coupler. The camera head receives optical image from the connected laparoscope and converts optical image into electronic signal using the incorporated image sensor. The Image Processing Unit serves as the control center of the system and should be connected to a compatible light source in order to provide visualization. It can be connected to a 4K video monitor via one of the video cables provided to display image in real time: DVI cable, HDMI cable, 12G-SDI cable, and 3G-SDI cable. The proposed system is a reusable device and provided non-sterile. The Camera Head should be cleaned and high-level disinfected prior to the first use and after every subsequent use. The recommended compatible Light Source is OPTO-LED104K (510k exempted, product code: NTN).