VisiRad XR
Imidex Inc.VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.
Intended Use
VisiRad XR is a computer-aided detection device intended to identify and mark regions of interest suspicious for lung nodules and masses on chest radiographs in patients over 21 years old, used as an aid after initial physician interpretation in outpatient or emergency department settings.
Technology
VisiRad XR is a SaMD product that uses machine learning algorithms to detect lung nodules and masses (6-60mm) from DICOM chest X-ray images, outputting secondary DICOM images with annotated regions of interest. It functions as a second-read tool, hanging behind the primary image in standard DICOM protocol and is deployed via secure cloud-based processing.
Performance
Performance was validated through standalone and clinical testing, showing VisiRad XR improves radiologist detection accuracy of pulmonary nodules and masses with a sensitivity of 83%, average false positives per image of 1.5, and statistically significant improvement in Area Under the Curve (AUC) compared to unaided readings. The device demonstrated consistent performance across patient demographics and imaging hardware with a moderate software risk level.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/3/2022
10 months - 2
FDA Approval
8/3/2023
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