Radiology AI Directory

FDA-cleared profile

Viz ICH

Viz.ai, Inc.

Authorized purpose: Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist for review.

Stroke and ICH triageAcute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist for review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist for review.

Evidence takeaway

Evidence from the reviewed source record: FDA K210209 reports 387 NCCT studies from two U.S. clinical sites, with approximately 50.6% ICH-positive and 49.4% ICH-negative cases; trained neuroradiologists established ground truth. Overall sensitivity was 95% (95% CI 91%-98%) and specificity 96% (95% CI 92%-98%), meeting the prespecified 80% goals. AUC was 0.97, and mean alerting time was 0.49+/-0.08 minutes versus 18.3+/-14.2 minutes for standard-of-care notification; AUC and latency are separate endpoints. Subgroup estimates were reported by site, age, gender, hemorrhage subtype, slice thickness, scanner manufacturer/model, volume threshold, and reconstruction method.

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
Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist for review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained clinicians; notifications are directed to neurovascular or neurosurgical specialists, with treating-physician discussion required before care decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Acute hospital-network workflow parallel to standard-of-care interpretation; image analysis is hosted on Viz.ai servers and notifications are available through the mobile module.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel specialist-notification and communication workflow; it prioritizes review without marking or altering original images and is not a diagnostic or full-patient-evaluation substitute.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Acute-setting non-contrast CT images of the brain from DICOM-compliant imaging devices and modalities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Notification of suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist, push/toggle notifications, patient/study/image DICOM information, and a compressed non-diagnostic CT preview through the Viz VIEW mobile application.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Mobile previews may be compressed and are informational only, not diagnostic beyond notification. Clinicians must view non-compressed images on a diagnostic viewer, perform full patient evaluation, and discuss care with the treating physician; the device must not be relied on to make or confirm a diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K210209
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Head/brain; suspected intracranial hemorrhage.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-03-23
  • 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 image-analysis algorithm is hosted on Viz.ai servers and receives DICOM studies forwarded from CT scanners; the Viz VIEW mobile module provides notifications and non-diagnostic previews. The packet does not establish a specific PACS/RIS/EHR route, interface version, or current commercial configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

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

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

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

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

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

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Viz ICH; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
FDA K210209 reports 387 NCCT studies from two U.S. clinical sites, with approximately 50.6% ICH-positive and 49.4% ICH-negative cases; trained neuroradiologists established ground truth. Overall sensitivity was 95% (95% CI 91%-98%) and specificity 96% (95% CI 92%-98%), meeting the prespecified 80% goals. AUC was 0.97, and mean alerting time was 0.49+/-0.08 minutes versus 18.3+/-14.2 minutes for standard-of-care notification; AUC and latency are separate endpoints. Subgroup estimates were reported by site, age, gender, hemorrhage subtype, slice thickness, scanner manufacturer/model, volume threshold, and reconstruction method.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Overall Viz ICH sensitivity: 95% (95% CI 91%-98%) across 387 NCCT studies from two U.S. sites, with ground truth established by trained neuroradiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The 80% figure is the prespecified goal; AUC, alert latency, and subgroup sensitivity are separate endpoints.

Reported specificity
Overall Viz ICH specificity: 96% (95% CI 92%-98%) across the same 387 NCCT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This corrects the active-row mixture of 95% and 80% and keeps overall specificity distinct from subgroup estimates and AUC.

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

Viz ICH regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K210209
  • Samplen=387
  • Sites2
  • IndependenceIndependence not established

K210209

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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 2026-09-09

No public price or quote for the exact K210209 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K210209. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
9Source classes checked
2Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 2 PubMed and 2 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 2 PubMed and 2 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, fda device recall, literature index, trial registry, 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 K210209: Viz ICH

    U.S. Food and Drug Administration - Published 2021-03-23 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Viz ICH model card (K210209)

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

    Scope: intendedUsers, output, limitations, reportedSensitivity, reportedSpecificity, 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. openFDA exact recall query for K210209

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

    Scope: postmarketSafety

Research history

  1. K210209 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K252421

JLK-NCCT

JLK, Inc.

Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...

Modality
CT/CTA
Anatomy
Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
Decision
2026-03-24
Stroke and ICH triageAcute triage and notification
FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.

Modality
CT/CTA
Anatomy
Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
Decision
2025-08-26
Stroke and ICH triageAcute triage and notification
FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
Stroke and ICH triageAcute triage and notification