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 and 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

PCCPFDA source did not state this

Cybersecurity addressedNo

Validation studies (2)

Standalone

n=2,202 cases

endpoints: demonstrate AUROC in standalone performance greater than 0.903

Reader study (MRMC)

n=258 cases

endpoints: evaluate the effectiveness of Lunit INSIGHT DBT by comparing the clinical performance of radiologists with CAD and without CAD assistance

Reported performance (3 observations)

aurocas written: “auc”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)”

aurocas written: “AUROC for CAD-assisted interpretation”0.915CI 0.874 - 0.955

source quote (p.8)

“when that of CAD-assisted interpretation was 0.915 (95% CI: 0.874 - 0.955)”

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
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). 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).