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…

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.

TGA Public Summary