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 HDS, Viz Volume Plus, Viz ICH+
Viz.ai, Inc.
Authorized purpose: Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
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: Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain (intracranial hyperdensities, lateral ventricles, and midline shift) Input: DICOM non-contrast head CT series acquired at a single time point from a compliant imaging device or modality.
- Who uses it? Intended users: Physicians.
- What does the software produce? Output: DICOM summary and segmentation series: a summary slice with overlays and measurements, plus RGB segmentation overlays on the input series for intracranial hyperdensities and lateral ventricles with midline-shift information and volume measurements, returned with the original NCCT series to a preconfigured PACS.
- What is its most important limitation? Key limitation: Single-time-point NCCT only and limited to the stated intracranial hyperdensity, lateral-ventricle, and midline-shift structures. The output should be reviewed with the original images by a physician; overlay colors are visual differentiators only and have no independent meaning. The reviewed FDA text does not state a sample size or establish diagnostic sensitivity, specificity, or a clinical outcome claim.
Clinical takeaway
Clinical role: Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
Evidence takeaway
Evidence from the reviewed source record: FDA K232363 reports clinical testing against ground truth established by trained radiologists. Upper 95% CI bounds for mean absolute error were below 7.5 mL for total intracranial hyperdensity volume, 3 mL for each lateral-ventricle volume, and 2 mm for midline-shift distance. Dice lower confidence bounds exceeded 70% for hyperdensities and both lateral ventricles, with stratification by site, demographics, slice thickness, scanner, protocol, and estimated quantity; the reviewed FDA text does not state the study sample size.
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
- Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
- Intended users
- Physicians.
- Care setting and population
- Hospital radiology and PACS workflow; the FDA summary describes return to a hospital server or customer DICOM node but the indication does not restrict facility type.
- Workflow role
- Post-acquisition automatic labeling, segmentation, visualization, and quantification with cloud processing and return of reviewable results to PACS.
- Required input
- DICOM non-contrast head CT series acquired at a single time point from a compliant imaging device or modality.
- Output and human action
- DICOM summary and segmentation series: a summary slice with overlays and measurements, plus RGB segmentation overlays on the input series for intracranial hyperdensities and lateral ventricles with midline-shift information and volume measurements, returned with the original NCCT series to a preconfigured PACS.
- Limitations
- Single-time-point NCCT only and limited to the stated intracranial hyperdensity, lateral-ventricle, and midline-shift structures. The output should be reviewed with the original images by a physician; overlay colors are visual differentiators only and have no independent meaning. The reviewed FDA text does not state a sample size or establish diagnostic sensitivity, specificity, or a clinical outcome claim.
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
- Viz HDS is hosted on Viz.ai's cloud server, receives NCCT head scans, and returns DICOM summary and segmentation series to a customer-configured DICOM node such as PACS. Exact interfaces, versions, and local compatibility require confirmation.
- 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.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Viz HDS, Viz Volume Plus, Viz ICH+; 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
- FDA K232363 reports clinical testing against ground truth established by trained radiologists. Upper 95% CI bounds for mean absolute error were below 7.5 mL for total intracranial hyperdensity volume, 3 mL for each lateral-ventricle volume, and 2 mm for midline-shift distance. Dice lower confidence bounds exceeded 70% for hyperdensities and both lateral ventricles, with stratification by site, demographics, slice thickness, scanner, protocol, and estimated quantity; the reviewed FDA text does not state the study sample size.
- 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.
Viz HDS, Viz Volume Plus, 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 K232363
- IndependenceIndependence not established
K232363
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 K232363 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 K232363. 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 K232363 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
22Fields 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
-
FDA K232363: Viz HDS, Viz Volume Plus, Viz ICH+
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Viz HDS, Viz Volume Plus, Viz ICH+ model card (K232363)
Scope: intendedUsers, output, 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 K232363
Scope: postmarketSafety
Research history
-
K232363 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
Alternatives
Related tools to compare
FDA-cleared K211222
qER-Quant
Qure.ai Technologies
Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
- Modality
- CT/CTA
- Anatomy
- Brain; intracranial hyperdensities, lateral ventricles, and midline shift
- Decision
- 2021-07-30
FDA-cleared K251151
Rapid CTA 360
iSchemaView
Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-07-16
FDA-cleared K243294
Brainomix 360 e-ASPECTS
Brainomix Limited
Brainomix 360 e-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-02-14
FDA-cleared K231570
StrokeViewer Perfusion
NICo-Lab B.V.
Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-12-14