FDA 510(k)

EFAI 骨套件 XR 骨齡評估系統 (BAP-XR-100)

K 號：K234042 · 2024-06-07

決定日期2024-06-07

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Ever Fortune.Ai, Co., Ltd. 為申請人之記錄

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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