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The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical 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 (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the VISERA ELITE III Surgical 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 biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the VISERA ELITE III Surgical Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.

The following subject devices of the OLYMPUS VISERA ELITE III Surgical Imaging System are identical to and unchanged from the VISERA ELITE III Surgical Imaging System (K242067):

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model Number: OLYMPUS OTV-S700) – OLYMPUS OTV-S700 is a video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.

  • OTV-S700 3D UPGRADE PACK (Model Number: OLYMPUS MAJ-2511) – A function activation portable memory key accessory that unlocks the 3D software function when connected with VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to enable 3D observation mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model Number: OLYMPUS CLL-S700) – A LED light source that provides examination light to a video endoscope and a camera head.

• 4K Camera Head OLYMPUS CH-S700-XZ-EA (Model Number: OLYMPUS CH-S700-XZ-EA) – A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (Endoscopic diagnosis), treatment and observation.

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