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 LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions. This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs *2D Imaging not intended for pediatric use.