Device Category Dossier

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

Device Category Dossier for X-ray system, diagnostic, general-purpose, application program software. Australian ARTG records, sponsors, device class —…

Software programs or routines that add specific image processing and/or analysis capabilities to general-purpose x-ray imaging system configurations operate by performing image processing of x-ray images, integrating patient data from hospital information systems, sending diagnostic images to picture archiving systems, and communicating exposure requests to and receiving results from x-ray devices . These applications are used in orthopaedic contexts for both paediatric and adult patients to analyse spinal deformities, degenerative diseases, and lower limb alignment disorders through angle and length measurements in patients aged seven years and older .