FDA 510(k) Application Details - K120106

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K120106
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	APIXIA INC. 18688 SAN JOSE AVE. INDUSTRY, CA 91748 US Other 510(k) Applications for this Company
Contact	ERIC HUANG 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	01/13/2012
Decision Date	05/07/2012
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