Radiology AI Directory

FDA-cleared profile

Lunit INSIGHT DBT

Lunit Inc.

Authorized purpose: Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.

Breast imagingDetection and CADe
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: Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.

Evidence takeaway

Evidence from the reviewed source record: FDA K231470 reports standalone testing on 2,202 DBT exams (1,100 negative/benign and 1,102 cancer) from US imaging facilities using Hologic and GE equipment. Standalone AUROC was 0.928 (95% CI 0.917-0.939; p < 0.0001). The 258-exam MRMC study with 15 MQSA-qualified/US board-certified radiologists compared patient-level LOS AUROC: CAD-assisted 0.915 (0.874-0.955) versus unassisted 0.897 (0.858-0.936), difference 0.017 (0.000-0.034), p = 0.0498.

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 suspected breast-cancer lesions in screening DBT exams from compatible systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians interpreting screening mammograms.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
US imaging facilities/healthcare institutions performing screening mammography.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent detection and characterization reading aid (CADe/x), not a replacement for physician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Screening female-population DBT exams from compatible DBT systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Lesion type, location, lesion-level/case-level abnormality score, and outlines/markings of regions suspected for breast cancer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not a replacement for complete interpreting-physician review or clinical judgment; intended for screening mammography of the female population and compatible DBT systems.
  • 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
K231470
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Breast
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-06
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
On-premise
  • 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.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Lunit INSIGHT DBT; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท 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 K231470 reports standalone testing on 2,202 DBT exams (1,100 negative/benign and 1,102 cancer) from US imaging facilities using Hologic and GE equipment. Standalone AUROC was 0.928 (95% CI 0.917-0.939; p < 0.0001). The 258-exam MRMC study with 15 MQSA-qualified/US board-certified radiologists compared patient-level LOS AUROC: CAD-assisted 0.915 (0.874-0.955) versus unassisted 0.897 (0.858-0.936), difference 0.017 (0.000-0.034), p = 0.0498.
  • 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.

Lunit INSIGHT DBT regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231470
  • Samplen=2202
  • IndependenceIndependence not established

K231470

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 K231470 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 K231470. 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
2026-09-20Last searched
22Fields reviewed
9Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 0 PubMed and 1 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

  1. FDA K231470: Lunit INSIGHT DBT

    U.S. Food and Drug Administration - Published 2023-11-06 - 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. Lunit INSIGHT DBT model card (K231470)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies

  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 K231470

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

    Scope: postmarketSafety

Research history

  1. K231470 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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