FDA 510(k) Application Details - K250750

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K250750
Device Name	System, X-Ray, Mobile
Applicant	DK Medical Systems Co., Ltd 52, Chupalsandan 1-Gil, Paengseong-Eup Pyeongtaek-Si 17998 KR Other 510(k) Applications for this Company
Contact	Sung-moon Hong Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2025
Decision Date	07/18/2025
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