Radiology AI Directory

FDA-cleared profile

DrAid™ for Liver Segmentation

VinBrain Joint Stock Company

Support trained professionals in visualizing, evaluating, measuring, and reporting liver and physician-identified liver lesions on multiphase CT; it does not generate diagnoses or potential findings directly.

Oncology quantification
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
Support trained professionals in visualizing, evaluating, measuring, and reporting liver and physician-identified liver lesions on multiphase CT; it does not generate diagnoses or potential findings directly.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained professionals including physicians and technicians; VinBrain and trained technicians carry out installation and deployment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Healthcare facility or hospital using standard hospital/clinic workstations; the FDA-labeled population is older than 22 years.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Semi-automated liver segmentation and quantitative measurement aid with manual seed-point and boundary editing and report generation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Multiphase DICOM CT images with slice thickness <= 3.0 mm from patients older than 22 years; contrast-enhanced CT scans were used in the reported validation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Editable liver segmentation mask; manual or physician-identified lesion segmentation; liver volume, lesion volume, maximum lesion diameter, lesion position, visualization, multiplanar reconstruction, and reporting outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Does not generate diagnoses or potential findings directly; qualified professionals make image interpretations and clinical decisions. The stated multiphase CT, slice-thickness <= 3.0 mm, adult, and DICOM scope applies. Installation and deployment are described as being carried out by VinBrain and trained technicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K241543
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Liver and physician-identified liver lesions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-12-06
  • 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
Web-based application running on standard hospital/clinic workstations with DICOM CT processing, viewer/manual editing, reporting, and results export. The exact PACS, RIS, EHR interface and hosting model are not established by the packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for DrAid™ for Liver Segmentation; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

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
FDA K241543 reports validation on 450 contrast-enhanced CT scans from 150 patients (age 60 +/- 12) at U.S. medical institutions, with ground truth from three U.S. board-certified radiologists. Liver segmentation had mean Dice 0.9649 (95% CI 0.9631-0.9667) and HD95 1.7061 (95% CI 1.5595-1.8526). Liver-volume measurement mean volume error was 2.7269% (95% CI 2.4308%-3.0230%). Subgroup and scanner analyses were also reported; no sensitivity or specificity disease-classification endpoint was reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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.

DrAid™ for Liver Segmentation regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241543
  • Samplen=450
  • IndependenceIndependence not established

K241543

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K241543 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K241543. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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.

Exact FDA record reviewedStatus
2026-09-08Last searched
22Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting 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 scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 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, 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

  1. FDA K241543: DrAid™ for Liver Segmentation

    U.S. Food and Drug Administration - Published 2024-12-06 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. DrAid™ for Liver Segmentation model card (K241543)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K241543

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K241543 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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