ChestLink

Primary DI

04779050430117

Basic UDI-DI Code

477905043MDSCL100X8

Reference

1

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Oxipit, UAB

ChestLink automatically and autonomously (without the involvement of a radiologist) evaluates a chest X-ray study. The software is indicated to automatically detect actionable radiological findings on chest radiographs. After this analysis, one of two actions is performed: (1) If ChestLink is confident that a study has no actionable radiological findings, a report is automatically generated. The study is not reported on by a trained radiologist. (2) If ChestLink cannot confidently rule out the presence of actionable radiological findings, the study is directed to be reported on by a radiologist.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).