All apps · Imaging & AI diagnostics

Is VideaHealth FDA approved or cleared?

Yes. VideaHealth by VideaHealth, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2022, latest decision in 2025.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	VideaHealth
Maker	VideaHealth, Inc.
Care area	Imaging & AI diagnostics
What it does	AI-powered dental imaging analysis platform for oral healthcare
FDA	510(k), latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	videa.ai
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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