FDA 510(k) Application Details - K130638

Device Classification Name	More FDA Info for this Device
510(K) Number	K130638
Device Name	ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
Applicant	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 BEST 5694 PC NL Other 510(k) Applications for this Company
Contact	KLIEN VAN DAM 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	03/11/2013
Decision Date	06/28/2013
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