FDA 510(k) Application Details - K122457

Device Classification Name	More FDA Info for this Device
510(K) Number	K122457
Device Name	GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
Applicant	GE HEALTHCARE 283, RUE DE LA MINIERE BUC 78530 FR Other 510(k) Applications for this Company
Contact	MALCA 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	08/13/2012
Decision Date	01/02/2013
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