FDA 510(k) Application Details - K222080

Device Classification Name	More FDA Info for this Device
510(K) Number	K222080
Device Name	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
Applicant	SG Healthcare CO LTD 10, Yangnyeong-ro, Yangpyeong-ri, Moga-myeon Seoul 17408 KR Other 510(k) Applications for this Company
Contact	Byung Ju Kang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2022
Decision Date	10/06/2022
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