FDA 510(k) Application Details - K012953

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K012953
Device Name	System, X-Ray, Mammographic
Applicant	MEDX, INC. 3456 NORTH RIDGE AVE., #100 ARLINGTON HEIGHTS, IL 60004 US Other 510(k) Applications for this Company
Contact	FLOYD R ROWAN 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	09/04/2001
Decision Date	11/30/2001
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