FDA 510(k) Application Details - K212889

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K212889
Device Name	System, X-Ray, Tomography, Computed
Applicant	Siemens Medical Solutions USA Inc. 810 Innovation Drive Knoxville, TN 37932 US Other 510(k) Applications for this Company
Contact	Clayton Ginn 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	09/10/2021
Decision Date	03/28/2022
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