FDA 510(k) Application Details - K102573

Device Classification Name	Unit, X-Ray, Intraoral   More FDA Info for this Device
510(K) Number	K102573
Device Name	Unit, X-Ray, Intraoral
Applicant	ADVANCED IMAGE SCIENCE, INC. 1999 SOUTH BASOM AVENUE, SUITE 700 CAMPBELL, CA 95008 US Other 510(k) Applications for this Company
Contact	PAUL ROCKWELL Other 510(k) Applications for this Contact
Regulation Number	872.1810   More FDA Info for this Regulation Number
Classification Product Code	EAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2010
Decision Date	06/30/2011
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