# K213628: VBrain

- Pathway: 510(k) (Special)
- Applicant: Vysioneer, Inc.
- Decided: Dec 16, 2021 after 29 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: 16 generations back to K954874 (1996). 103 ancestors in all.
No later device cites it as a predicate yet.
1 of 104 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 4.
- K212116: VBrain-OAR, Vysioneer, Inc. (2021) Summary page 4.

## 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 and organs at risk in the brain (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain is intended to be used on adult patients only. VBrain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor and organs at risk (brain stem, eyes, optic nerves, optic chiasm) in the brain 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, and contours of organs at risk in the brain; it is not intended to be used with images of other brain tumors or other body parts. The user must know the tumor type when they use VBrain. VBrain also contains the automatic image registration feature to register volumetric medical image data. (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images. 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/K213628
Methodology: https://510kreport.com/methodology