Lunit INSIGHT DBT v1.1

K242652

Lunit Inc. · cleared 2024-10-04 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems.”

Algorithmartificial intelligence technology that has been trained via deep learning

source quote (p.6)

“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 addressedNo

Validation studies (2)

Bench

sample size not stated

Standalone

sample size not stated

endpoints: demonstrate AUROC in standalone performance greater than 0.903

Reported performance (1 observation)

aurocas written: “auc”0.931CI 0.920 – 0.941

source quote (p.8)

“The subject device's AUROC in the standalone performance analysis was 0.931 (95% CI: 0.920 – 0.941) with statistical significance (p < 0.0001), which exceeded the acceptance criteria of the primary endpoint.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).