K234042

Substantially Equivalent

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

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: QIH
Advisory panel: Radiology
Date received: 2023-12-21
Decision date: 2024-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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Data sourced from openFDA. This site is unofficial and independent of the FDA.