FDA 510(k) Application Details - K241114

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K241114
Device Name	System, Image Processing, Radiological
Applicant	EwooSoft Co., Ltd. 801-ho, Vatechnetworks Bldg. 13, Samsung 1-ro 2-gil Hwaseong-si 18449 KR Other 510(k) Applications for this Company
Contact	Young Seok Kim Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2024
Decision Date	07/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review