FDA 510(k) Application Details - K101373

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K101373
Device Name	System, X-Ray, Mammographic
Applicant	IZI MEDICAL PRODUCTS INC. 7020 TUDSBURY RD. BALTIMORE, MD 21244 US Other 510(k) Applications for this Company
Contact	HELEN SHAFER 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	05/17/2010
Decision Date	09/15/2010
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