All apps · Imaging & AI diagnostics

Is aycan mobile FDA approved or cleared?

Yes. aycan mobile by Aycan Digitalsysteme GmbH is named in the FDA register with a 510(k) clearance, latest decision in 2012.

In the EU: CE class IIa, found in EUDAMED. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed).

At a glance

Product	aycan mobile
Maker	Aycan Digitalsysteme GmbH
Care area	Imaging & AI diagnostics
What it does	Mobile DICOM viewer for medical imaging and radiological workflow
FDA	510(k), latest decision 2012
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	Class IIa
EU certificate	Not visible in EUDAMED yet (checked 18 October 2026)
Website	aycan.de
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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