FDA 510(k) Application Details - K092004

Device Classification Name	More FDA Info for this Device
510(K) Number	K092004
Device Name	GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
Applicant	GE HEALTHCARE 3000 N. GRANDVIEW BLVD. WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	ALAN TOTAH 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	07/02/2009
Decision Date	08/25/2009
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