FDA 510(k)

ARIETTA x10

Número K: K231941 · 2023-11-20

RequerenteFUJIFILM Healthcare Americas Corporation

Data da decisão2023-11-20

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARIETTA x10 is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K231941. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARIETTA x10?

ARIETTA x10 is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231941.

When did ARIETTA x10 receive FDA 510(k) clearance?

ARIETTA x10 received FDA 510(k) clearance on 2023-11-20, under 510(k) number K231941.

Who is the listed applicant for ARIETTA x10?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIETTA x10?

The FDA product code for ARIETTA x10 is IYN.

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Fonte oficial

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