FDA 510(k) Application Details - K051025

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K051025
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	DANIEL F PHELAN Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2005
Decision Date	05/13/2005
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