FDA 510(k) Application Details - K181830

Device Classification Name	More FDA Info for this Device
510(K) Number	K181830
Device Name	Azurion R2.0
Applicant	Philips Medical Systems Nederland BV Veenpluis 4-6 Best 5684PC NL Other 510(k) Applications for this Company
Contact	Owen Callaghan 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	07/09/2018
Decision Date	08/02/2018
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