# K191278: Rsi-Mri+

- Pathway: 510(k) (Traditional)
- Applicant: Multimodal Imaging Services Corporation (Dba Healthlytix)
- Decided: Nov 19, 2019 after 190 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173744: ProFuse CAD, Eigen (2018) Summary page 4.

## Indications for 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. 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. RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions. RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.

Source page: https://510kreport.com/device/K191278
Methodology: https://510kreport.com/methodology