Viz Subdural+, Viz SUBDURAL PLUS

K250354

Viz.ai, Inc. · cleared 2025-06-10 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to process and analyze non-contrast CT (NCCT) scans of the head to automatically measure the collections in the subdural region in the brain and midline shift.”
Algorithmlocked artificial intelligence machine learning (AI/ML) algorithm; deep-learning convolutional neural networks
source quote (p.5)
“Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to process and analyze non-contrast CT (NCCT) scans of the head to automatically measure the collections in the subdural region in the brain and midline shift. Both devices' algorithms use similar pipelines with similar steps to measure their indicated structures and both devices' algorithms use deep-learning convolutional neural networks with similar architectures.”
Adaptive (vs locked)No
source quote (p.5)
“Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to process and analyze non-contrast CT (NCCT) scans of the head to automatically measure the collections in the subdural region in the brain and midline shift.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=203 cases · 2 site(s)

endpoints: Mean Absolute Error (MAE); DICE Score

Reported performance (1 observation)

diceas written: “Subdural Collection Volume - DICE Score Mean”0.73CI 68% - 77%
source quote (p.10)
“73% (68% - 77%)”

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
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K250354