FDA 510(k) Application Details - K191468

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K191468
Device Name	System, X-Ray, Tomography, Computed
Applicant	Siemens Medical Solutions, USA, Inc 2501 N. Barrington Road Hoffman Estates, IL 60192 US Other 510(k) Applications for this Company
Contact	Cynthia Busch 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	06/03/2019
Decision Date	07/03/2019
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