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BreastUS

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies · 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 #K251474
Product codeQDQ
Decision dateFeb 6, 2026
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

Founded2019-05-14 · via wikidata

Cite this page

RadPigeon. "Median LCS (internal name) / eyonis LCS (trade name) (1.0) (Median Technologies)." AI Devices registry. https://radpigeon.news/ai/device/median-lcs-internal-name-eyonis-lcs-trade-name-1-0

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