# K212116: VBrain-OAR

- Pathway: 510(k) (Traditional)
- Applicant: Vysioneer, Inc.
- Decided: Oct 12, 2021 after 97 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.
1 later device descends from it; 1 cites it directly.
1 of 103 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.

## Most influential descendants
- K213628: VBrain (2021), 0 descendants of its own

## Indications for use
VBrain-OAR is a software device intended to assist trained radiotherapy personnel including, but not limited to, radiologists, radiation oncologists, neurosurgeons, radiation therapists, dosimetrists, and medical physicists, during their clinical workflows of brain tumor radiation therapy treatment planning, by providing initial object contours of organs at risk in the brain (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain-OAR is intended to be used on adult patients only. VBrain-OAR uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) organs at risk (brain stem, eyes, optic nerves, optic chiasm) in the brain on MRI images for trained radiotherapy personnel’s attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain-OAR does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain-OAR is intended only for contouring and generating contours of organs at risk in the brain; it is not intended to be used with images of other body parts. VBrain-OAR 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. Radiation therapy treatment personnel must finalize (confirm or modify) the contours generated by VBrain-OAR, 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/K212116
Methodology: https://510kreport.com/methodology