X-ray image interpretive software

Intended purpose

The Lunit INSIGHT CXR is a Computer-Assisted Detection (CADe) software device based on an artificial intelligence algorithm intended for use as a concurrent reading aid for interpreting physicians reading chest radiographs, to detect, localize, identify, and characterize suspicious abnormal radiological findings. As an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that considers other relevant information from the image or patient history.