FDA 510(k) Application Details - K111103

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K111103
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	RF CO., LTD 6-5-3 BEAUNE HONKOMAGOME 2F HONKOMAGOME BUNKYO-KU, TOKYO 113-0021 JP Other 510(k) Applications for this Company
Contact	KOJI KUBO 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	04/20/2011
Decision Date	01/05/2012
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