FDA 510(k) Application Details - K181403

Device Classification Name	More FDA Info for this Device
510(K) Number	K181403
Device Name	Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
Applicant	GE Healthcare 283 Rue de la Miniere Buc 78530 FR Other 510(k) Applications for this Company
Contact	Michel Genuer 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	05/29/2018
Decision Date	11/02/2018
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