FDA 510(k) Application Details - K011987

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K011987
Device Name	System, X-Ray, Mammographic
Applicant	LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. DANBURY, CT 06810 US Other 510(k) Applications for this Company
Contact	ROAIDA RIZKALLAH 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	06/26/2001
Decision Date	07/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review