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FLUOBEAM® LX and FLUOBEAM® LX Red are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM® LX and FLUOBEAM® LX Red are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries. The FLUOBEAM® LX and FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX and FLUOBEAM® LX Red devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

FLUOBEAM® LX and FLUOBEAM® LX Red are imaging systems intended to provide realtime near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX and FLUOBEAM® LX Red are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries. FLUOBEAM® LX and FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX and FLUOBEAM® LX Red devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues. FLUOBEAM® LX and FLUOBEAM® LX Red enable surgeons to observe fluorescent images of parathyroid glands, blood vessels and related tissue perfusion. Fluorescence can be observed as a result of natural fluorescence of parathyroid glands or as a result of a fluorescent product, indocyanine green (ICG), injected intravenously into patients before the surgery allowing the perfusion assessment. Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM® LX and FLUOBEAM® LX Red consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT™ LX or FLUOSOFT™ LX Red imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT™ LX imaging software and the FLUOSOFT™ LX Red imaging software on the computer. This special 510(k) premarket notification is intended to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the co-packaging with ICG.