AI-Rad Companion Brain MR
Siemens Healthcare GmBhAI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.
Intended Use
AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images with functionalities including automated segmentation and quantitative analysis of brain structures and white matter hyperintensities, comparison with normative data, and visualization of results.
Technology
AI-Rad Companion Brain MR automates volumetric analysis and visual assessment of brain structures from T1 MPRAGE and T2 FLAIR MR datasets, using algorithms for segmentation, quantification, and comparison to normative data. It provides a 3D overlay map of white matter hyperintensities and integrates results directly into the PACS system.
Performance
Performance testing included software validation comparing white matter hyperintensity segmentation with manual annotations from expert radiologists over a dataset of 89 subjects with varied neurological status. Metrics such as Dice scores and reproducibility were reported, showing equivalent performance to predicate and reference devices. Verification and validation testing were performed including unit, system, and integration tests, conforming to relevant standards for medical device software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/24/2021
4 months - 2
FDA Approval
4/15/2022
Other devices from Siemens Healthcare GmBh
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
- AI-Rad Companion (Pulmonary)2024 • 510K
- Syngo Carbon Clinicals2023 • 510K
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