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Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. 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 OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.

The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists. Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the L12 Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

780 nm 1688 4K Camera System : The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists. 780 nm L11 LED Light Source with AIM and Safelight Cable: Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780nm Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using SPY AGENT TM GREEN (indocyanine green for injection, USP) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The 780nm AIM System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and. (5) SPY AGENT "M GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

1688 4K Camera System with Advanced Imaging Modality (AIM): The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons and urologists. L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable: Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediativ patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Additionally, the L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near-infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures. Precision S 4K Sinuscope: The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including thinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years ofage.

The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT 104 GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.

1688 4K Camera System with Advanced Imaging Modality (AIM): The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, sinuscopy, sinuscopy and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. The 1688 Video Camera is indicated for use in adults and pediatric patients aged one month or older. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable: Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using endoscope visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month or older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Upon interstitial administration of SPY AGENT GREEN, the L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures. Advanced Imaging Modality (AIM) HD Autoclavable Laparoscope: The AIM HD Autoclavable Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for adults and pediatric patients aged one month or older, when the dimensions of the AIM HD Autoclavable Laparoscope are appropriate for the patient size and anatomy.

The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) SPY AGENT GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.

1688 4K Camera System with Advance Imaging Modality: The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. L11 LED Light Source with Advanced Imaging Modality: Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging. The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.

Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The AIM Light Source (L10 and L11 LED Light Source) and SafeLight™ Cable are part of the AIM (Advanced Imaging Modality) System. The AIM System is an endoscopic real-time visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures, respectively. The AIM Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination. The SafeLight Cable transmits light from the light source to an endoscope during endoscopic procedures.

Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery. The Stryker Infrared Fluorescence Imaging System consists of the following main components: - . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum; - . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately); - A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately) - An imaging agent kit containing ICG ● The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.