BreastUS

Lunit INSIGHT DBT

🇰🇷Lunit, Inc. · Breast CAD (tomosynthesis)

What it does

Marks areas of interest on mammo / dbt images to support the radiologist's read as a second pair of eyes; the radiologist makes the call.

Who it's for

Radiologists who want a detection aid on these studies and programs aiming to improve consistency.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K231470

Product codeQDQ

Decision dateNov 6, 2023

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Company🇰🇷Lunit, Inc.

Foundedunknown

Cite this page

RadPigeon. "Lunit INSIGHT DBT (Lunit, Inc.)." AI Devices registry. https://radpigeon.news/ai/device/lunit-insight-dbt-2

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.