Regulatory Information

Axial3D's 510K cleared AI-driven, cloud-based segmentation system is intended for use for the automated conversion of imaging information from a medical scanner to a 3D output.

The 3D outputs are validated to be used for clinical use and treatment planning for orthopaedic, orthopaedic trauma, cardiovascular, and maxillofacial applications and should be used in conjunction with other diagnostic tools and expert clinical judgement.

The Axial3D Cloud Segmentation Service can be used to create digital 3D files or to fabricate physical replicas using additive manufacturing methods when printed in conjunction with the materials and printers below. Other printers may be used to create 3D anatomical models for demonstration and educational purposes with Axial3D Cloud-Based Segmentation Service, however, these have not been validated by Axial3D and the quality of such printers cannot be guaranteed.

For Axial3D's complete QIH approval, you can reference the links below.

• K232841
• K231607

Please also refer to the Axial3D Operator Manual for additional instructions and guidance for printing and processing 3D models.