Device Dossier
X-ray image interpretive software
Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIa, sponsor Taevas Life Sciences). ARTG record, intended…
- GMDN category: X-ray image interpretive software
- Sponsor: Taevas Life Sciences
Intended purpose
Rayvolve is designed to help radiologists and emergency physicians to detect and localize medical abnormalities standard X-rays. Rayvolve helps detect: ● Fractures on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg, knee, and femur. ● Bone measures' abnormalities (angle/length) on lower limb (including hip, knees, foot) and spine. ● Bones characterisation for bone age abnormalities estimation on hand. Rayvolve can analyze X-rays of adult and pediatric patients. The radiographs analyzed are: Computed Radiography (CR), Radio Fluoroscopy (RF) et Digital Radiography (DX). Rayvolve is indicated for adults and the pediatric population.