FDA 510(k) Application Details - K183637

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K183637
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Cruxell Corp. A-405, Migun Techno World II 187 techno 2-ro, Yuseong-gu Daejeon 34025 KR Other 510(k) Applications for this Company
Contact	Daeseok Hwang 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	12/26/2018
Decision Date	02/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review