FDA 510(k) Application Details - K212624

Device Classification Name	More FDA Info for this Device
510(K) Number	K212624
Device Name	EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Applicant	Ever Fortune. AI Co., Ltd. Rm. D, 8F , NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung 403020 TW Other 510(k) Applications for this Company
Contact	Chen Ming-Fong 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	08/18/2021
Decision Date	04/04/2022
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