# K252922: Neosoma Brain Mets

- Pathway: 510(k) (Traditional)
- Applicant: Neosoma, Inc.
- Decided: Dec 17, 2025 after 93 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: 16 generations back to K954874 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203235: VBrain, Vysioneer, Inc. (2021) Summary page 5.

## Indications for use
The Neosoma software uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) known or previously diagnosed brain tumors on MRI images for qualified and trained medical professionals. The technology is meant for informational purposes only and not intended to replace the clinician’s current standard practice of manual contouring. The software does not alter the original MRI image, nor is it intended to be used to detect tumors for diagnosis. The software is intended to be used on adult patients only. When using the Neosoma software in a radiation oncology planning workflow, or other clinical workflows, it is intended for generating Gross Tumor Volume (GTV) contours. For all clinical workflows, medical professionals must finalize (confirm or modify) the contours generated by the Neosoma software, as necessary, using an external platform available at the facility that supports DICOM viewing/editing functions, such as image visualization software and treatment planning system.

Source page: https://510kreport.com/device/K252922
Methodology: https://510kreport.com/methodology