RSI-MRI+ is software designed to assist clinicians by automatically processing diffusion-weighted and anatomical MRI images. It enhances the visibility of restricted diffusion areas, fuses these with anatomical images, and uses AI to segment and quantify the prostate, providing helpful reports. This helps radiologists and urologists more efficiently analyze prostate MRI data.
Intended Use
RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. It is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images and provides automatic prostate segmentation, quantification, and reporting of derived image metrics. Not intended for pediatric populations or to diagnose, treat or prevent diseases.
Technology
RSI-MRI+ is standalone software that accepts DICOM images, performs diffusion-weighted MRI analysis with a Restricted Signal Map for improved conspicuity, fuses diffusion data with anatomical T2-weighted MR images, and uses AI deep learning for automatic prostate segmentation and automated reporting. Outputs are standard DICOM format compatible with commercial PACS systems.
Performance
Software verification and validation testing confirmed that RSI-MRI+ operates as intended, processing DICOM images and producing expected outputs. Performance testing demonstrated increased conspicuity of the Restricted Signal Map, accuracy of automated prostate segmentation compared to manual radiologist segmentations, and diffusion signal normalization across scanners. Testing used retrospective labeled clinical data and met predetermined acceptance criteria, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/13/2019
6 months - 2
FDA Approval
11/19/2019
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