FDA 510(k)

EFAI RTSUITE CT HCAP-分割系统

K号: K231928 · 2023-09-25

决定日期2023-09-25

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Ever Fortune.Ai, Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253163EFAI ERSUITE CT 腹膜炎评估系统（APPEN-CT-100）K251306Seg Pro V3 (RT-300)K242821EFAI Chestsuite XR 误位ETT评估系统（ETT-XR-100）K241923EFAI 神经套件CT 中线移位评估系统（MLS-CT-100）K234042EFAI Bonesuite XR 骨龄评估系统（BAP-XR-100）K240291EFAI CARDIOSUITE CTA 急性主动脉综合征评估系统

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官方来源

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