FDA 510(k)

EFAI Bonesuite XR 骨龄评估系统（BAP-XR-100）

K号: K234042 · 2024-06-07

决定日期2024-06-07

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) 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 2024-06-07 under 510(k) number K234042. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)?

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K234042.

When did EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) receive FDA 510(k) clearance?

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) received FDA 510(k) clearance on 2024-06-07, under 510(k) number K234042.

Who is the listed applicant for EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)?

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 Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)?

The FDA product code for EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is QIH.

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。

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