FDA 510(k)

ADAS 3D

Número K: K253969 · 2026-06-29

Data da decisão2026-06-29

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADAS 3D is the device name listed in this FDA 510(k) record. The listed applicant is Adas3D Medical S.L.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253969. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADAS 3D?

ADAS 3D is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Adas3D Medical S.L.. The 510(k) number is K253969.

When did ADAS 3D receive FDA 510(k) clearance?

ADAS 3D received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253969.

Who is the listed applicant for ADAS 3D?

The FDA 510(k) record lists Adas3D Medical S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAS 3D?

The FDA product code for ADAS 3D is QIH.

Outros registros que listam Adas3D Medical S.L. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K240791ADAS 3D K230803ADAS 3D K212421ADAS 3D K210850ADAS 3D

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Fonte oficial

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