FDA 510(k) Application Details - K123433

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K123433
Device Name	System, Tomography, Computed, Emission
Applicant	CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BOULEVARD LOS ANGELES, CA 90048-1869 US Other 510(k) Applications for this Company
Contact	GEOFF POLLARD, PROGRAM MANAGER Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2012
Decision Date	02/26/2013
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