# K230150: OptimMRI

- Pathway: 510(k) (Traditional)
- Applicant: Rebrain, Sas
- Decided: Jul 21, 2023 after 183 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 2 generations back to K050438 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162830: SIS Software, Surgical Information Sciences, Inc. (2017) Summary page 4.

## Most influential descendants
- K242054: OptimMRI (v2) (2024), 0 descendants of its own

## Indications for use
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.

Source page: https://510kreport.com/device/K230150
Methodology: https://510kreport.com/methodology