BreastUS + EU

Lunit INSIGHT DBT

🇰🇷Lunit · Breast CAD (tomosynthesis)

What it does

Marks and scores suspicious areas on tomosynthesis (3D mammography) to support the radiologist's read as a second pair of eyes.

Who it's for

Breast-imaging radiologists and screening programs aiming to improve cancer detection and reading 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 #—

Product codeQDQ

Decision dateJun 1, 2023

PanelRadiology

EU (CE)

StatusCE-marked

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

Vendor

Company🇰🇷Lunit

Founded2013 · via manual

Websitewww.lunit.io

Cite this page

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

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