IMAGE NAVIGATION LTD

Image Navigation Ltd specializes in dental stereotactic surgery systems. These devices are designed to provide precise, image-guided assistance during oral and maxillofacial surgical procedures. The systems integrate real-time imaging and navigation technology to enhance surgical planning and execution, particularly for complex dental interventions where accuracy is critical.

Image Navigation Ltd is based in the United States. The company’s focus is on developing and manufacturing medical devices tailored to the US market, adhering to regulatory standards applicable in that region.

Image Navigation Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices under FDA oversight, helping healthcare providers verify the identity and regulatory status of the company’s products.

Image Navigation Ltd’s dental stereotactic surgery systems fall under the FDA’s Class II classification. This classification indicates that the devices pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls. The classification reflects the need for precise manufacturing and performance standards for surgical navigation tools.