AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.
Intended Use
AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases.
Technology
The device uses machine and deep learning algorithms to segment the heart and aorta, quantify coronary calcium, and measure aorta diameters, enhanced with an improved aorta segmentation algorithm using additional training data. It supports generating DICOM Structured Reports compliant with TID 1500 and operates in both cloud and edge deployment models.
Performance
Non-clinical tests, software validation, and bench testing demonstrated the device meets FDA safety and performance guidance. Clinical validation on representative cohorts showed substantially equivalent performance to the predicate device with high accuracy in aorta segmentation and diameter measurements, including measurements at new locations for max ascending and descending aorta diameters.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/4/2022
8 months - 2
FDA Approval
4/6/2023
Other devices from Siemens Medical Solutions U.S.A.
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