FDA 510(k) Application Details - K243696

Device Classification Name	More FDA Info for this Device
510(K) Number	K243696
Device Name	AVIEW CAC
Applicant	Coreline Soft Co., Ltd. 12, Donggyo-ro 19-gil, Mapo-gu Seoul 04001 KR Other 510(k) Applications for this Company
Contact	Hyeyi Park 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	11/29/2024
Decision Date	02/14/2025
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