Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Viz ANEURYSM, Viz ANX
Viz.ai, Inc.
Authorized purpose: Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
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: Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Head Input: Head CT/CTA images.
- Who uses it? Intended users: Trained radiologists.
- What does the software produce? Output: Study-level flags and prioritization for suspected aneurysm, with compressed non-diagnostic preview images; original images are not altered.
- What is its most important limitation? Key limitation: Parallel to standard care; previews are informational only; not for diagnosis or sole decision-making; full evaluation remains required; detection is limited to aneurysms at least 4 mm.
Clinical takeaway
Clinical role: Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
Evidence takeaway
Evidence from the reviewed source record: The performance analysis included 315 scans: 67 positive and 248 negative. Sensitivity was 93% (83%-98%), specificity was 89% (85%-93%), and the area under the receiver operating characteristic curve (AUC) was 0.967 (95% CI: 0.936-0.997).
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
- Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Trained radiologists.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Head CT/CTA images.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Output and human action
- Study-level flags and prioritization for suspected aneurysm, with compressed non-diagnostic preview images; original images are not altered.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Parallel to standard care; previews are informational only; not for diagnosis or sole decision-making; full evaluation remains required; detection is limited to aneurysms at least 4 mm.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
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
- K213319
- Modality
- CT/CTA
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Head
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2022-02-18
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- On-premise
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.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Viz ANEURYSM, Viz ANX; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- The performance analysis included 315 scans: 67 positive and 248 negative. Sensitivity was 93% (83%-98%), specificity was 89% (85%-93%), and the area under the receiver operating characteristic curve (AUC) was 0.967 (95% CI: 0.936-0.997).
The replacement retains only the packet's reported case counts, sensitivity, specificity, and AUC and removes the non-textual accuracy characterization.
- Reported sensitivity
- 93% (95% CI: 83%, 98%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 89% (95% CI: 85%, 93%)
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 Aneurysm, Viz ANX 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 K213319
- Samplen=315
- Sites2
- IndependenceIndependence not established
K213319
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 K213319 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 K213319. 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 care setting and population: Confirm the intended care setting, patient population, and service line.
- 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 K213319 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
27Fields reviewed
10Source 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, 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 K213319: Viz ANEURYSM, Viz ANX
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Viz Aneurysm, Viz ANX model card (K213319)
Scope: intendedUsers, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, 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 K213319
Scope: postmarketSafety
Research history
-
K213319 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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