FDA 510(k)

EFAI PACS Picture Archiving and Communication System

Número K: K211257 · 2021-09-10

Data da decisão2021-09-10

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EFAI PACS Picture Archiving and Communication System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211257. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EFAI PACS Picture Archiving and Communication System?

EFAI PACS Picture Archiving and Communication System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K211257.

When did EFAI PACS Picture Archiving and Communication System receive FDA 510(k) clearance?

EFAI PACS Picture Archiving and Communication System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211257.

Who is the listed applicant for EFAI PACS Picture Archiving and Communication System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI PACS Picture Archiving and Communication System?

The FDA product code for EFAI PACS Picture Archiving and Communication System is LLZ.

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Fonte oficial

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