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 2026-09-08FDA-cleared profile
Viz ICH
Viz.ai, Inc.
Authorized purpose: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
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 triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain Input: NCCT images of the head acquired on a local healthcare network and transmitted by a DICOM router to the backend server.
- Who uses it? Intended users: Hospital networks and trained clinicians; notifications are sent to an appropriate specialist such as a neurovascular specialist or neurosurgeon.
- What does the software produce? Output: A notification to a neurovascular or neurosurgical specialist that suspected intracranial hemorrhage has been identified, with analyzed NCCT images viewable through a non-diagnostic mobile application.
- What is its most important limitation? Key limitation: Mobile-app preview images may be compressed and are informational only, not for diagnostic use beyond notification; Viz ICH is not a substitute for full patient evaluation or diagnosis and is contraindicated for non-contrast CT scans acquired on non-GE scanners.
Clinical takeaway
Clinical role: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
Evidence takeaway
Evidence from the reviewed source record: A retrospective study evaluated Viz ICH on 261 non-contrast CT scans from two U.S. clinical sites. Sensitivity was 93% (87%-97%), specificity was 90% (84%-94%), and AUC was 0.96; average time to alerting a specialist was 0.49±0.15 minutes versus 38.2±84.3 minutes for standard-of-care notification.
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 triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- Hospital networks and trained clinicians; notifications are sent to an appropriate specialist such as a neurovascular specialist or neurosurgeon.
These are the user and specialist descriptions stated in the exact indication and device description.
- Care setting and population
- Adult patients; the institutional care setting requires local confirmation.
Conservative normalization of explicit wording in an exact-submission source.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- NCCT images of the head acquired on a local healthcare network and transmitted by a DICOM router to the backend server.
The exact device description states the NCCT head-image and DICOM-router input path.
- Output and human action
- A notification to a neurovascular or neurosurgical specialist that suspected intracranial hemorrhage has been identified, with analyzed NCCT images viewable through a non-diagnostic mobile application.
The exact packet supports specialist notification and non-diagnostic mobile image viewing.
- Limitations
- Mobile-app preview images may be compressed and are informational only, not for diagnostic use beyond notification; Viz ICH is not a substitute for full patient evaluation or diagnosis and is contraindicated for non-contrast CT scans acquired on non-GE scanners.
These are the exact preview, diagnostic-use, full-evaluation, and scanner-manufacturer boundaries in the packet.
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
- K193658
- Modality
- CT/CTA
The exact packet identifies the subject imaging modality as non-contrast CT and does not establish the dossier's CT/CTA value. Controlled directory display reconciled from exact FDA wording: Non-contrast CT (NCCT). -> CT/CTA.
- Anatomy
- Brain
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2020-03-18
- 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
- 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
- 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.
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
- A retrospective study evaluated Viz ICH on 261 non-contrast CT scans from two U.S. clinical sites. Sensitivity was 93% (87%-97%), specificity was 90% (84%-94%), and AUC was 0.96; average time to alerting a specialist was 0.49±0.15 minutes versus 38.2±84.3 minutes for standard-of-care notification.
The exact packet reports these study design, performance, and notification-time results; the dossier's unsupported metric list is replaced.
- Reported sensitivity
- 93%; 80%; 95%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- 93%; 80%; 95%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
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 K193658 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 K193658. 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 K193658 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
24Fields reviewed
10Source 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, 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 K193658: Viz ICH
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Viz ICH model card (K193658)
-
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 K193658
Scope: postmarketSafety
Research history
-
K193658 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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