FDA 510(k) Application Details - K071787

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K071787
Device Name	System, X-Ray, Mammographic
Applicant	DJA DISTRIBUTORS, LLC 2225 E. FLAMINGO ROAD SUITE 204 LAS VEGAS, NV 89119 US Other 510(k) Applications for this Company
Contact	BETH BROMBERG Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2007
Decision Date	10/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review