FDA 510(k) Application Details - K221552

Device Classification Name	More FDA Info for this Device
510(K) Number	K221552
Device Name	EFAI ChestSuite XR Pneumothorax Assessment System
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	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2022
Decision Date	11/08/2022
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