FDA 510(k) Application Details - K033244

Device Classification Name	More FDA Info for this Device
510(K) Number	K033244
Device Name	DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
Applicant	GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. MAIL STOP W-400 WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2003
Decision Date	10/16/2003
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