FDA 510(k) Application Details - K243611

Device Classification Name	More FDA Info for this Device
510(K) Number	K243611
Device Name	JLK-SDH
Applicant	JLK, Inc. JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul 06141 KR Other 510(k) Applications for this Company
Contact	Dongmin Kim 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	11/22/2024
Decision Date	03/03/2025
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