# K183193: MREplus+ Software

- Pathway: 510(k) (Traditional)
- Applicant: Resoundant, Inc.
- Decided: Aug 1, 2019 after 255 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: 3 generations back to K913770 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020483: Advantage Workstation 4.1, GE Medical Systems (2002) Summary page 5.

## Indications for use
MREplus+ Software is an assisted ROI drawing tool for liver MRE and Fat/Water images and is used for receiving, display, ROI selection, and analysis generation. It displays to a trained reader MRE and Fat/Water images, preliminary ROIs that it calculates from these images, and statistical analysis calculated from the ROIs and images. ROIs and images are presented in a way for review and, optionally, modification by the trained reader.

Source page: https://510kreport.com/device/K183193
Methodology: https://510kreport.com/methodology