FDA 510(k) Application Details - K230241

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K230241
Device Name	System, X-Ray, Stationary
Applicant	SG Healthcare CO LTD 10 Yongnyeong-ro, Moga-myeon Ichen-Si Seoul 17408 KR Other 510(k) Applications for this Company
Contact	Byung Ju Kang Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2023
Decision Date	02/23/2023
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