FDA 510(k) Application Details - K132087

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K132087
Device Name	System, X-Ray, Tomography, Computed
Applicant	PHILIPS HEALTHCARE 49 SPADINA AVENUE #310 TORONTO M5V 2J1 CA Other 510(k) Applications for this Company
Contact	DAVE SZCZUPAKOWSKI Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2013
Decision Date	07/24/2013
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	Y
Expedited Review