The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraop erative cholangiography. The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive s urgery 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 Scivita 4KINSIGHT ICG Imaging 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 bil iary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessel s and lymph nodes.
An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.