Device Dossier

X-ray system, diagnostic, general-purpose, application program software

Device Dossier for X-ray system, diagnostic, general-purpose, application program software (X-ray system, diagnostic, general-purpose, application…

Intended purpose

This cloud-based software is intended for orthopedic applications in both pediatric and adult populations. 2D X-ray images acquired in EOS imaging’s imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment. For additional assessment, alignment parameters compared to published normative values may be available. This product serves as a tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older. Clinical judgment and experience are required to properly use the software.

TGA Public Summary