FDA 510(k) Application Details - K113350

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K113350
Device Name	System, Tomography, Computed, Emission
Applicant	GE HEALTHCARE 4 HAYOZMA STREET TIRAT HACARMEL 30200 IL Other 510(k) Applications for this Company
Contact	ELI WERNER 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	11/14/2011
Decision Date	12/05/2011
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