Device Dossier

X-ray system, diagnostic, computed tomography, limited view field

Device Dossier for X-ray system, diagnostic, computed tomography, limited view field (X-ray system, diagnostic, computed tomography, limited view field,…

Intended purpose

The InReach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and ankle regions, to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow, knee, foot or ankle condition is considered necessary. * Patient parameters: 50lbs to 400lbs

TGA Public Summary