FDA 510(k) Application Details - K011624

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K011624
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER 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	05/25/2001
Decision Date	06/08/2001
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	Y
Expedited Review