FDA 510(k)

EFAI RTSUITE CT HCAP-Segmentation System

Número K: K231928 · 2023-09-25

Data da decisão2023-09-25

Código do produtoQKB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EFAI RTSUITE CT HCAP-Segmentation 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 2023-09-25 under 510(k) number K231928. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EFAI RTSUITE CT HCAP-Segmentation System?

EFAI RTSUITE CT HCAP-Segmentation System is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231928.

When did EFAI RTSUITE CT HCAP-Segmentation System receive FDA 510(k) clearance?

EFAI RTSUITE CT HCAP-Segmentation System received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231928.

Who is the listed applicant for EFAI RTSUITE CT HCAP-Segmentation 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 RTSUITE CT HCAP-Segmentation System?

The FDA product code for EFAI RTSUITE CT HCAP-Segmentation System is QKB.

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Outros registros que listam Ever Fortune.Ai, Co., Ltd. como candidato(a)

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Fonte oficial

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