ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Viz LVO ContaCT; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
Viz LVO ContaCT
Viz.ai, Inc.
Authorized purpose: Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond 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 to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond notification.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond notification.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain, specifically the terminal internal carotid artery and MCA-M1 vessels Input: Stroke-protocoled CTA images of the head acquired on CT scanners in the acute setting and forwarded to Viz.ai's Backend Server in DICOM format; the algorithm analyzes the terminal ICA and MCA-M1 vessels for suspected LVO.
- Who uses it? Intended users: Hospital networks and trained clinicians, with notifications directed to a neurovascular specialist
- What does the software produce? Output: A notification that a suspected large vessel occlusion has been identified and that the images should be reviewed by a neurovascular specialist; the mobile application provides a unique suspected-LVO patient list and compressed, non-diagnostic CT previews, while non-compressed images remain for diagnostic-viewer review.
- What is its most important limitation? Key limitation: The device is notification-only and identification of suspected findings is not diagnostic. Mobile previews are compressed and informational only; notified clinicians must view non-compressed images on a diagnostic viewer and perform full patient evaluation and relevant discussion before care decisions. The software analyzes imaging data only, must not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis, and does not establish a rule-out capability.
Clinical takeaway
Clinical role: Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond notification.
Evidence takeaway
Evidence from the reviewed source record: K223042 is a Special 510(k) for changes to the Viz LVO indications describing the intended regions analyzed. The FDA summary explicitly states that performance data were not included in the premarket notification; supporting software verification and validation testing was provided to demonstrate implementation of the changes. No subject-device sensitivity, specificity, AUC, or clinical-outcome performance estimate is established by this packet.
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 to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond notification.
- Intended users
- Hospital networks and trained clinicians, with notifications directed to a neurovascular specialist
- Care setting and population
- Hospital networks and acute neurovascular clinical workflow
- Workflow role
- Notification-only parallel triage and specialist communication independent of the standard-of-care reading workflow; users can receive and toggle suspected-LVO notifications, view a patient list, and review informational mobile previews.
- Required input
- Stroke-protocoled CTA images of the head acquired on CT scanners in the acute setting and forwarded to Viz.ai's Backend Server in DICOM format; the algorithm analyzes the terminal ICA and MCA-M1 vessels for suspected LVO.
- Output and human action
- A notification that a suspected large vessel occlusion has been identified and that the images should be reviewed by a neurovascular specialist; the mobile application provides a unique suspected-LVO patient list and compressed, non-diagnostic CT previews, while non-compressed images remain for diagnostic-viewer review.
- Limitations
- The device is notification-only and identification of suspected findings is not diagnostic. Mobile previews are compressed and informational only; notified clinicians must view non-compressed images on a diagnostic viewer and perform full patient evaluation and relevant discussion before care decisions. The software analyzes imaging data only, must not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis, and does not establish a rule-out capability.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The LVO algorithm is hosted on Viz.ai's Backend Server and receives applicable stroke-protocol CTA images in DICOM format from CT imaging devices or the connected imaging workflow; the Viz VIEW mobile module presents notifications and non-diagnostic previews. The reviewed FDA packet does not establish a specific PACS, RIS, EHR, interface version, or current deployment configuration.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
- K223042 is a Special 510(k) for changes to the Viz LVO indications describing the intended regions analyzed. The FDA summary explicitly states that performance data were not included in the premarket notification; supporting software verification and validation testing was provided to demonstrate implementation of the changes. No subject-device sensitivity, specificity, AUC, or clinical-outcome performance estimate is established by this packet.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
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
No public price or quote for the exact K223042 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K223042. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K223042 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
20Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, 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
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FDA K223042: Viz LVO ContaCT
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Viz LVO model card (K223042)
Scope: intendedUsers, careSetting, output, anatomy
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K223042
Scope: postmarketSafety
Research history
-
K223042 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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