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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234042
510(k) Type
Traditional
Applicant
Ever Fortune.AI Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
6/7/2024
Days to Decision
169 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234042
510(k) Type
Traditional
Applicant
Ever Fortune.AI Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
6/7/2024
Days to Decision
169 days
Submission Type
Summary