FDA 510(k) Application Details - K150823

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K150823
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	EDLEN IMAGING LLC 16441 NORTH 91ST STREET SUITE 102 SCOTTSDALE, AZ 85250 US Other 510(k) Applications for this Company
Contact	Nick Radachi 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	03/27/2015
Decision Date	08/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review