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FDA-cleared K191278

RSI-MRI+

MultiModal Imaging Services Corporation (dba HealthLytix)

Authorized purpose: RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.

Modality
MRI
Anatomy
Prostate
Decision
2019-11-19