FDA 510(k) Application Details - K241923

Device Classification Name	More FDA Info for this Device
510(K) Number	K241923
Device Name	EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-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	Chang Joseph Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	12/06/2024
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