FDA 510(k) Application Details - K192766

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K192766
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Fsusen Technology Co., Ltd 1F, 3# Building, Tongfuyu Industrial Zone, Taoyuan Street, Nanshan District Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Elsa Li Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2019
Decision Date	12/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review