ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Lunit INSIGHT DBT v1.1; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
Lunit INSIGHT DBT v1.1
Lunit Inc.
Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.
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
- Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.
- Intended users
- Physicians interpreting screening mammograms.
- Care setting and population
- The screening population described in the FDA intended use; the institutional care setting requires local confirmation.
Conservative normalization of explicit wording in an exact-submission source.
- Workflow role
- Concurrent detection and characterization reading aid (CADe/x), not a replacement for physician review.
- Required input
- Screening mammograms of the female population acquired as DBT exams from compatible DBT systems.
- Output and human action
- Lesion type, location, lesion-level and case-level abnormality scores, and outlines/markings of regions suspected for breast cancer.
- Limitations
- Not a replacement for complete interpreting-physician review or clinical judgment; intended for screening mammography of the female population and compatible DBT systems.
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
- 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
- FDA K242652 packet reports standalone performance for Lunit INSIGHT DBT v1.1. AUROC was 0.931 (95% CI 0.920-0.941; p < 0.0001) against a prespecified >0.903 criterion. The packet does not provide a clinical reader study or numeric sensitivity/specificity.
- 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.
Lunit INSIGHT DBT v1.1 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 K242652
- IndependenceIndependence not established
K242652
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 K242652 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 K242652. 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 K242652 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
2026-09-08Last searched
21Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
1Awaiting 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 1 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
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FDA K242652: Lunit INSIGHT DBT v1.1
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Lunit INSIGHT DBT v1.1 model card (K242652)
Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies
-
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 K242652
Scope: postmarketSafety
Research history
-
K242652 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
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