AI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc.AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.
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. It provides automatic segmentation and quantitative analysis of individual brain structures, quantitative comparison with normative data, and visualization for reporting.
Technology
AI-Rad Companion Brain MR uses automated algorithms to segment and analyze volumetric properties of 30 predefined brain structures from T1 MPRAGE MR datasets, comparing patient data to age-matched healthy reference populations. It stores results in PACS and includes enhancements such as a customizable deviation map and cloud-based deployment capabilities.
Performance
Nonclinical software validation and bench testing, including unit, system, and integration tests, were conducted to verify functionality and performance. The device complies with multiple FDA-recognized standards for software and medical devices. No clinical testing was performed; equivalence established by verification, validation, and comparison to predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
6 months - 2
FDA Approval
6/17/2020
Other devices from Siemens Medical Solutions USA, Inc.
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