FDA 510(k) Application Details - K050663

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K050663
Device Name	System, X-Ray, Mammographic
Applicant	TRAXYZ MEDICAL, INC. 290 TURNPIKE RD SUITE 6 #323 WESTBORO, MA 01581 US Other 510(k) Applications for this Company
Contact	F. DAVID ROTHKOPF 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	03/15/2005
Decision Date	04/08/2005
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