FDA 510(k) Application Details - K062039

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K062039
Device Name	System, X-Ray, Mammographic
Applicant	GIOTTO USA, LLC 11460 N MERIDIAN ST., STE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	Allison Scott 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	07/19/2006
Decision Date	09/11/2006
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	N
Expedited Review