Smile Dx®

Cube Click, Inc. · Analyzer, Medical Image

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

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 #K242437

Product codeMYN

Decision dateMay 14, 2025

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

CompanyCube Click, Inc.

Foundedunknown

Cite this page

RadPigeon. "Smile Dx® (Cube Click, Inc.)." AI Devices registry. https://radpigeon.news/ai/device/smile-dx

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