Radiology AI Directory

FDA-cleared profile

Viz Subdural+, Viz SUBDURAL PLUS

Viz.ai, Inc.

Viz Subdural+ labels, visualizes, and quantifies subdural collections from single-time-point non-contrast head CT, reporting collection grayscale value, total volume, widest width, and midline shift as annotated DICOM images for physician review with original CT.

Quantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Viz Subdural+ labels, visualizes, and quantifies subdural collections from single-time-point non-contrast head CT, reporting collection grayscale value, total volume, widest width, and midline shift as annotated DICOM images for physician review with original CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Trained physicians interpreting head CT, including radiologists and other qualified clinicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Adult head-CT interpretation and acute neuroimaging workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Segmentation, measurement, and visualization support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
Single-time-point non-contrast head CT in DICOM format; the device analyzes subdural-space collections and does not replace review of the original CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
Annotated DICOM images and measurements for collection grayscale value, total volume, widest width, and midline shift; overlay opacity corresponds to the grayscale value in the native CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
Physicians must review the original images and full patient context; the output is assistive measurement/visualization and not a substitute for clinical interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K250354
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-06-10
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The submission describes DICOM input and annotated DICOM image output for review; specific PACS/workstation compatibility and routing were not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Baseline deployment category preserved; current hosting region, retention, and tenant configuration were not established.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Current onboarding, competency, and support commitments were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Local acceptance testing, production monitoring, update control, and drift review were not established.

Annotated DICOM measurement output

The exact submission describes DICOM head-CT input and annotated DICOM images with subdural collection volume, widest width, midline shift, and grayscale-linked overlays.

exact submission · checked 2026-09-06
Source

Viz Subdural family care coordination

Viz's official Subdural page describes automated acute/chronic subdural detection, care-team coordination, and a secure cloud-native workflow; those current family claims are not assumed for the exact K250354 measurement build.

product family · checked 2026-09-07
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
Retrospective validation compared measurements with trained neuroradiologist reference values using 203 cases for volume/thickness and 151 cases for midline shift from two clinical sites.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Viz Subdural+ measurement validation

  • DesignRetrospective validation against trained neuroradiologist reference measurements
  • Population203 head-CT cases for collection volume and widest thickness; 151 cases for midline shift, from two clinical sites
  • Scopeexact submission
  • Tested versionViz Subdural+ submitted in K250354; build not stated
  • Samplen=203
  • Sites2
  • IndependenceIndependence not established

K250354

The FDA tables report mean absolute error and overlap statistics; unit labels were not normalized here where the extracted table did not expose them consistently.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

No public amount, range, currency, geography, or contract term was established.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

No payer or CMS policy review was performed in this worker cohort.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor press release, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) K250354: Viz Subdural+

    U.S. Food and Drug Administration - Published 2025-06-10 - Accessed 2026-09-06

    Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Viz Subdural+, Viz SUBDURAL PLUS model card (K250354)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Viz.ai receives FDA clearance for subdural measurements

    Viz.ai - Published 2025-06-12 - Accessed 2026-09-07

    Scope: exactProductIdentity, productCapabilities, implementationCapabilities

  8. Viz Subdural official product page

    Viz.ai - Accessed 2026-09-07

    Scope: productFamilyWorkflow, implementationCapabilities

Research history

  1. K250354 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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Brain midline-shift measurement on adult non-contrast CT

Modality
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Anatomy
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Decision
2025-05-28
Quantification and segmentation