FDA 510(k) Application Details - K964990

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K964990
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	HITACHI MEDICAL SYSTEMS AMERICA, INC. 12300 TWINBROOK PARKWAY, SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY 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	12/16/1996
Decision Date	02/26/1997
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