All apps · Imaging & AI diagnostics

Is ATUSA FDA approved or cleared?

Yes. ATUSA by Isono Health, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2022.

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

At a glance

Product	ATUSA
Maker	Isono Health, Inc.
Care area	Imaging & AI diagnostics
What it does	Automated 3D breast ultrasound system for breast imaging
FDA	510(k), latest decision 2022
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	atusamedical.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.

Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes

Other apps in Imaging & AI diagnostics

aycan mobile FDA verified
BoneView FDA FDA verified
Butterfly iQ FDA verified
CapsoCam Plus FDA verified
Cercare Medical Neurosuite FDA verified
Clarius Ultrasound App FDA verified
Denti.AI FDA verified
ImmersiveTouch FDA verified

All certified imaging apps and AI diagnostic tools

Search the full directory