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exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-authorized profile
ContaCT
Viz.Al, Inc.
ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, 1 independent of the standard of care workflow. ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
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
ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, 1 independent of the standard of care workflow. ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.
- Imaging and anatomy CT/CTA · Brain
- Workflow role Triage or notification support
- Required input CT angiogram images of the brain acquired in the acute setting
- Output and human action Notification of suspected large vessel occlusion
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
- ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, 1 independent of the standard of care workflow. ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
- Intended users
- Neurovascular specialist
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- CT angiogram images of the brain acquired in the acute setting
The exact indication states the image type, anatomy, and acute-setting scope.
- Output and human action
- Notification of suspected large vessel occlusion
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Identification of suspected findings is not for diagnostic use beyond notification. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
The exact decision summary states the notification-only, compressed-preview, diagnostic-viewer, full-evaluation, and diagnosis boundaries.
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
- DEN170073
- Modality
- CT/CTA
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Brain
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- De Novo
- Decision date
- 2018-02-13
- FDA status
- FDA-authorized
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for ContaCT; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- Study type: Stand-Alone Performance. Cases: 300. Sites: 2. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 87.8% (95% CI: 81.2% -92.5%. Reported specificity: 89.6% 95% CI: 83.7% -93.9%
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Reported sensitivity
- 87.8% (95% CI: 81.2% -92.5%
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 89.6% 95% CI: 83.7% -93.9%
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Viz LVO (ContaCT) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission DEN170073
- Samplen=300
- Sites2
- IndependenceIndependence not established
DEN170073
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 DEN170073 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 DEN170073. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 DEN170073 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
2026-09-19Last searched
25Fields reviewed
11Source classes checked
20Awaiting review PubMed leads
10Awaiting review trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA support assessed on 2026-09-19. Packet-supported facts: purpose, modality, anatomy, intendedUsers, output, evidenceSummary; packet-unavailable facts: input, limitations. Candidate literature and postmarket candidates remain in their existing review state. Automated exact-name discovery found 20 PubMed and 10 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, acr ai central product, fda de novo summary, fda device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA DEN170073: ContaCT
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, output, evidenceSummary, input, limitations
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Viz LVO (ContaCT) model card (DEN170073)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
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 DEN170073
Scope: postmarketSafety
Research history
-
DEN170073 FDA decision
Regulatory record
De Novo
-
Source-review record updated
Research record
fda record reviewed
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