FDA 510(k) Application Details - K151707

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K151707
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL HWASEONG-SI 445-170 KR Other 510(k) Applications for this Company
Contact	KEVIN KIM 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	06/24/2015
Decision Date	07/19/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review