AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc.AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.
Intended Use
Image processing software providing quantitative and qualitative analysis from previously acquired CT DICOM images for evaluation and assessment of cardiovascular diseases. Functions include heart segmentation and volume measurement, coronary calcium quantification, aorta segmentation, aortic diameter measurement, and threshold-based highlighting of enlarged diameters.
Technology
Software-only image post-processing application that uses deep learning algorithms to analyze CT chest data. It segments the heart and aorta, detects and quantifies coronary calcium, identifies anatomical landmarks on the aorta for diameter measurements according to AHA guidelines, and classifies measurements with threshold-based categories. Validated on non-cardiac chest CT from multiple CT vendors.
Performance
Performance was evaluated by software validation including non-clinical bench testing and clinical data-based software validation. The software demonstrated conformity with FDA consensus standards (DICOM, IEC 62304, ISO 14971). Clinical validation with retrospective studies showed high correlation (0.96) for coronary calcium volume compared to predicate device and average absolute aorta diameter measurement error of 1.6 mm. Testing supported claims of substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2018
9 months - 2
FDA Approval
9/10/2019
Other devices from Siemens Medical Solutions USA, Inc.
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