FDA 510(k) Application Details - K234042

Device Classification Name	More FDA Info for this Device
510(K) Number	K234042
Device Name	EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Applicant	Ever Fortune.AI Co., Ltd. Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd. West Dist. Taichung City 403020 TW Other 510(k) Applications for this Company
Contact	Joseph Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2023
Decision Date	06/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review