FDA 510(k) Application Details - K181343

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K181343
Device Name	System, Tomography, Computed, Emission
Applicant	Bracco Diagnostics Inc. 259 Prospect Plains Road, Building H Monroe Township, NE 08831 US Other 510(k) Applications for this Company
Contact	Patrice Marchildon 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	05/21/2018
Decision Date	06/12/2018
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