Lunit INSIGHT DBT

K231470

Lunit Inc. · cleared 2023-11-06 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Lunit INSIGHT DBT is a computer-assisted detection/diagnosis (CADe/x) software as a medical device that provides information about the presence, location and characteristics of lesions suspicious for breast cancer to assist interpreting physicians in making diagnostic decisions when reading digital breast tomosynthesis (DBT) images. The software automatically analyzes digital breast tomosynthesis slices via artificial intelligence technology that has been trained via deep learning.”
Algorithmartificial intelligence technology that has been trained via deep learning
source quote (p.5)
“The software automatically analyzes digital breast tomosynthesis slices via artificial intelligence technology that has been trained via deep learning.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=2,202 cases

endpoints: AUROC in standalone performance

Reader study (MRMC)

n=258 cases

endpoints: comparison of patient-level Level of Suspicion (LOS) area under the Receiver Operating Characteristic (ROC) curve between CAD-assisted and CAD-unassisted interpretation

Reported performance (3 observations)

aurocas written: “auc”0.915CI 0.874 - 0.955
source quote (p.8)
“AUROC for CAD-unassisted interpretation was 0.897 (95% CI 0.858 - 0.936), when that of CAD-assisted interpretation was 0.915 (95% CI: 0.874 - 0.955) with inter-test difference of 0.017 (95%: CI 0.000 - 0.034, P = 0.0498).”
aurocas written: “AUROC for standalone performance”0.928CI 0.917 - 0.939
source quote (p.8)
“The subject device's AUROC in the standalone performance analysis was 0.928 (95% CI: 0.917 - 0.939) with statistical significance (p < 0.0001), which exceeded the acceptance criteria of the primary endpoint.”
aurocas written: “AUROC for CAD-unassisted interpretation”0.897CI 0.858 - 0.936
source quote (p.8)
“AUROC for CAD-unassisted interpretation was 0.897 (95% CI 0.858 - 0.936), when that of CAD-assisted interpretation was 0.915 (95% CI: 0.874 - 0.955) with inter-test difference of 0.017 (95%: CI 0.000 - 0.034, P = 0.0498).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253796 (decision 2026-03-26) from Lunit, Inc. for a matching device line ("Lunit INSIGHT DBT (V1.2)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253796

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242652 (decision 2024-10-04) from Lunit Inc. for a matching device line ("Lunit INSIGHT DBT v1.1") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242652

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231470