AI-Rad Companion Brain MR

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

FDA Submission Metadata

Submission number

K253057

Decision date

January 2026

FDA panel

Radiology

Product code

QIH

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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