Radiology AI Directory

FDA-cleared profile

Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

DAFS automatically segments anatomy on DICOM Part 10 CT images and supports two- and three-dimensional visualization, editing, and area, volume, and intensity measurements for trained professionals.

Quantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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
DAFS automatically segments anatomy on DICOM Part 10 CT images and supports two- and three-dimensional visualization, editing, and area, volume, and intensity measurements for trained professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Trained healthcare professionals who review and edit radiological image-processing outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Clinical image-processing and review environments using CT data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Adjunct CT segmentation, vertebral labeling, visualization, measurement, editing, and reporting.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
DICOM Part 10 CT image studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Editable anatomical segmentations, vertebral landmarks, 2D/3D visualizations, measurements, and tabular or graphical reports.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
DAFS is an adjunct and does not provide diagnostic interpretation. K253944 is CT-only; current vendor PET or MR product-family features must not be attributed to this clearance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

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
K253944
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-03-16
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM Part 10 CT input with CSV, tabular, PDF, and graphical output functions described in the FDA summary; validate routing and identifier handling.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Software application on compatible computing infrastructure. Current DAFS Node materials may inform evaluation but are not exact K253944 deployment evidence.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only trained healthcare professionals who review and edit radiological image-processing outputs. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: DAFS is an adjunct and does not provide diagnostic interpretation. K253944 is CT-only; current vendor PET or MR product-family features must not be attributed to this clearance.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K253944 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM Part 10 CT input with CSV, tabular, PDF, and graphical output functions described in the FDA summary; validate routing and identifier handling.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. DAFS is an adjunct and does not provide diagnostic interpretation. K253944 is CT-only; current vendor PET or MR product-family features must not be attributed to this clearance.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: DAFS is an adjunct and does not provide diagnostic interpretation. K253944 is CT-only; current vendor PET or MR product-family features must not be attributed to this clearance.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

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
Exact-submission internal testing used 124 adult TCIA CT studies from multiple institutions and more than ten scanner models. Median vertebral slice error was zero and most major structures had mean Dice above 0.90; all outputs require professional review.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Independent validation subjects

124 subjects

  • EndpointCT studies excluded from model training
  • PopulationData Analysis Facilitation Suite (DAFS)
  • Tested versionDAFS cleared in K253944
Source

Vertebral median slice error

0 slices

  • EndpointAutomated versus reference vertebral landmarks
  • PopulationData Analysis Facilitation Suite (DAFS)
  • Tested versionDAFS cleared in K253944
Source

Major-structure mean Dice reference

0.9 DSC

  • EndpointMost major structures exceeded this reported value
  • PopulationData Analysis Facilitation Suite (DAFS)
  • Tested versionDAFS cleared in K253944
Source

K253944 FDA performance package for Data Analysis Facilitation Suite (DAFS)

  • DesignManufacturer independent internal validation against expert-reviewed manual reference standards
  • Population124 adult CT studies, 60 female and 64 male, from multi-institutional TCIA datasets with contrast and noncontrast scans
  • Scopeexact submission
  • Tested versionDAFS cleared in K253944
  • Samplen=124
  • IndependenceSponsor or vendor study

K253944

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K253944 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
24Fields reviewed
8Source classes checked
10Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 10 PubMed and 0 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, vendor product page, reimbursement policy, fda device recall, 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

  1. K253944 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. DAFS product-family overview

    Voronoi Health Analytics - Accessed 2026-09-03

    Scope: productFamily, workflowRole, deployment, implementationCapabilities, currentCommercialContext

Research history

  1. K253944 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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