VBrain-OAR

K212116

Vysioneer Inc. · cleared 2021-10-12 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“VBrain-OAR is a software device intended to assist trained radiotherapy personnel”

Algorithmartificial intelligence algorithm (i.e., deep learning neural networks)

source quote (p.3)

“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.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: clinically acceptable contours for organs at risk in the brain structures on an image of a patient; quality of the rigid registration of the registration algorithm module on images of multiple modalities, to demonstrate substantial equivalence to the predicate device

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K213628 (decision 2021-12-16) from Vysioneer Inc. for a matching device line ("VBrain") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213628

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).