Device Dossier
X-ray image interpretive software
Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIa, sponsor KD & A). ARTG record, intended purpose, GMDN…
- GMDN category: X-ray image interpretive software
Intended purpose
The Oxipit ChestEye software is intended to support trained radiologists when reporting on chest X-ray images. The final report must be approved by a trained radiologist. The software is a fully automatic computer assisted diagnosis solution. Based on collected data (deep neural network) the software analyses a given chest X-ray image. By function, ChestEye consists of three parts: ChestEye CAD, ChestEye Queue, and ChestEye Search. The software detects 75 radiological findings.