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 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.”
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
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

sample size not stated

endpoints: contouring (segmentation) performance; clinically acceptable contours for organs at risk in the brain structures on an image of a patient

Bench

sample size not stated

endpoints: quality of the rigid registration

Bench

sample size not stated

standards: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K212116