FDA 510(k) Application Details - K122918

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K122918
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	RAY CO., LTD 8920 WILSHIRE BLLVD SUITE 603 BEVERLY HILLS, CA 90211 US Other 510(k) Applications for this Company
Contact	ANDREW PAENG 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	09/24/2012
Decision Date	03/15/2013
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