VBrain

K203235

Vysioneer Inc. · cleared 2021-03-19 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“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.e., region of interest, ROI) on axial T1 contrast-enhanced brain MRI images.”
Algorithmartificial intelligence algorithm (deep learning neural networks)
source quote (p.3)
“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.”
Adaptive (vs locked)No
source quote (p.6)
“Although the proposed new device, VBrain, uses a data-driven deep learning-based algorithm for contouring of known brain tumors, the primary predicate MIM - MRT Dosimetry (K182624) uses a semi-automatic algorithm that requires user's input to start the contouring process. The specific design of the proposed device does not raise different questions of safety and effectiveness, because the new device only provides initial object contours of known (diagnosed) brain tumors for the medical professionals' attention, which are meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=116 cases · 4 site(s)

endpoints: lesion-wise sensitivity; false-positive rate; lesion-wise Dice coefficient; average Hausdorff distance; centroid distance

Bench

sample size not stated

endpoints: DICE similarity coefficients (DSC)

Reported performance (2 observations)

sensitivity90.3CI 86.1-93.7%
source quote (p.12)
“lesion-wise sensitivity of VBrain was observed to be 90.3% (95% CI: 86.1-93.7%)”
diceas written: “lesion-wise Dice similarity coefficient (DSC)”0.793CI 0.775-0.811
source quote (p.12)
“They were observed to be lesion-wise DSC: 0.793 (95% CI: 0.775-0.811)”

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
2
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K212116 (decision 2021-10-12) from Vysioneer Inc. for a matching device line ("VBrain-OAR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K212116

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/K203235