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Is ImmersiveTouch FDA approved or cleared?

Yes. ImmersiveTouch by ImmersiveTouch, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2014, latest decision in 2021.

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

At a glance

Product	ImmersiveTouch
Maker	ImmersiveTouch, Inc.
Care area	Imaging & AI diagnostics
What it does	Virtual reality platform for medical training and surgical planning
FDA	510(k), latest decision 2021
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	immersivetouch.com
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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