EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K-Number: K234042 · 2024-06-07
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2024-06-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under approval 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. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K234042.
When was EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) approved by the FDA?
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) received FDA 510(k) clearance on 2024-06-07, under approval number K234042.
What company makes EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)?
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is manufactured by Ever Fortune.Ai, Co., Ltd..
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.
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Official Source
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