# K203235: VBrain

- Pathway: 510(k) (Traditional)
- Applicant: Vysioneer, Inc.
- Decided: Mar 19, 2021 after 136 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- 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: 15 generations back to K954874 (1996). 101 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020) Summary page 4.
- K182624: MIM - MRT Dosimetry, Mim Software, Inc. (2018) Summary page 4.

## Most influential descendants
- K252190: DeepBT Detector-Plus (2026), 0 descendants of its own
- K252922: Neosoma Brain Mets (2025), 0 descendants of its own
- K250427: TAIMedImg DeepMets (2025), 0 descendants of its own
- K213628: VBrain (2021), 0 descendants of its own

## Indications for use
VBrain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors (i.c., region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor on MRI images for trained medical professionals’ attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain is intended only for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas on axial T1 contrast-enhanced MRI images; It is not intended to be used with images of other brain tumors. The user must know the tumor type when they use VBrain. VBrain is intended to be used on adult patients only. Medical professionals must finalize (confirm or modify) the contours generated by VBrain, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system.

Source page: https://510kreport.com/device/K203235
Methodology: https://510kreport.com/methodology