Audax D.O.O.

Audax D.O.O. specializes in developing software-based medical devices. Specifically, they create AudaxCeph, a cephalogram analysis software tool designed for orthodontic treatment planning. This software processes digital cephalometric radiographs to provide clinicians with detailed measurements and diagnostic reports, helping them evaluate skeletal and dental relationships.

Audax D.O.O. is based in the United States. While the company’s headquarters and primary operations are located there, the summary does not provide details on international offices or distribution. For specific global reach or regulatory presence, further inquiry into their device listings or direct contact would be necessary.

Audax D.O.O.’s devices, including AudaxCeph, are classified as Class II under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software used in specialized diagnostic or treatment planning applications.

Yes, Audax D.O.O.’s devices are listed in the FDA 510(k) registry. The 510(k) clearance process is used for devices that are substantially equivalent to legally marketed predicates, ensuring they meet applicable safety and performance standards before commercial distribution in the U.S. This registry provides transparency on cleared devices.