Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic s…

This camera system is designed for endoscopic and laparoscopic procedures within gastroenterology and urology, where high-resolution imaging is critical. It combines visible white light and near-infrared fluorescence imaging (NIR FI) to improve tissue contrast and diagnostic clarity. The NIR FI light source and CMOS sensor-based camera head enable better visualization of anatomical structures, aiding in precise procedural guidance—particularly useful in identifying subtle tissue differences or fluorescence markers during surgery.

The system is supplied as a modular setup and is designed to integrate with compatible fiberoptic laparoscopes, though exact compatibility depends on the manufacturer’s specifications. It includes a Camera Control Unit, Camera Head, NIR FI Light Source, Light Guide, and the laparoscope itself. The modular design allows for flexibility in setup, but users should confirm compatibility with their existing equipment to ensure proper functionality.

The system’s optical and electronic performance depends on proper storage and handling as outlined by the manufacturer. Components should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. If reusable parts are used, they must undergo standard medical device processing protocols to maintain sterility. The manufacturer’s guidelines should be followed to ensure longevity and compatibility with controllers like the FlexiVision NIR FI 4K UHD or NIR FI Full HD.

The system’s components can be either single-use or reusable, depending on the manufacturer’s specifications for each part. While the Camera Control Unit and NIR FI Light Source are likely designed for reuse with proper sterilization, other elements like the Camera Head or Light Guide may be single-use. Users should refer to the manufacturer’s instructions to determine the appropriate use and reprocessing protocols for each component to ensure safety and performance.

This camera system is classified under FDA Class II and has received Traditional 510(k) clearance (K221591), meaning it has been deemed substantially equivalent to a predicate device. It also complies with the EU Medical Device Regulation (MDR). Clinically, this classification ensures it meets established safety and effectiveness standards, but users should always follow the manufacturer’s instructions and local regulatory guidelines for proper implementation in procedures.