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
DrAid™ for Liver Segmentation
VinBrain Joint Stock Company
Authorized 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.
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: 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.
Overview status: Source-reviewed overview
- What does this software do? Authorized 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.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Liver and physician-identified liver lesions. 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.
- Who uses it? Intended users: Trained professionals including physicians and technicians; VinBrain and trained technicians carry out installation and deployment.
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: 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.
Evidence takeaway
Evidence from the reviewed source record: 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.
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.
- Intended users
- Trained professionals including physicians and technicians; VinBrain and trained technicians carry out installation and deployment.
- Care setting and population
- Healthcare facility or hospital using standard hospital/clinic workstations; the FDA-labeled population is older than 22 years.
- Workflow role
- Semi-automated liver segmentation and quantitative measurement aid with manual seed-point and boundary editing and report generation.
- 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.
- 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.
- 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.
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
- 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.
- Deployment and data flow
- Hybrid
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.
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 2026-09-08Evidence
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 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.
- 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.
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.
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 K241543 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 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.
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 K241543 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
23Fields 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
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FDA K241543: DrAid™ for Liver Segmentation
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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DrAid™ for Liver Segmentation model card (K241543)
Scope: intendedUsers, careSetting, 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 K241543
Scope: postmarketSafety
Research history
-
K241543 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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