FDA 510(k) Application Details - K163715

Device Classification Name	More FDA Info for this Device
510(K) Number	K163715
Device Name	Allura Xper R9
Applicant	PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 BEST 5684 PC NL Other 510(k) Applications for this Company
Contact	JEANETTE BECKER 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	12/30/2016
Decision Date	01/26/2017
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