FDA 510(k) Application Details - K091658

Device Classification Name	More FDA Info for this Device
510(K) Number	K091658
Device Name	GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
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	06/09/2009
Decision Date	06/29/2009
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