AI-Rad Companion Brain MR

AI-Rad Companion Brain MR is post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images. It performs automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities, compares results to normative data from healthy populations, and presents findings in numerical and visual formats for clinical reporting.

The subject device VA60 adds enhancements to white matter hyperintensities (WMH) and WMH follow-up features compared to predicate VA50, including support for 1.5T and 3T field strengths (previously 3T only), relaxed data consistency requirements between prior and current studies, multi-vendor support (Siemens, GE, Philips), and configurable follow-up time intervals of 14-180 days. The brain morphometry and morphometry follow-up features remain identical to the predicate.

IEC 62366-1 (usability engineering), ISO 14971 (risk management), IEC 62304 (software life cycle), DICOM PS 3.1–3.20 (digital imaging), ISO 15223-1 (device symbols), and IEC 82304-1 (health software safety). Compliance with FDA guidance documents on premarket submissions for device software (June 2023) and cybersecurity (September 2023) is documented.