FDA 510(k)

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

K-Number: K234042 · 2024-06-07

Decision Date2024-06-07

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Ever Fortune.Ai, Co., Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.