FDA 510(k) Application Details - K163286

Device Classification Name	More FDA Info for this Device
510(K) Number	K163286
Device Name	ARTIS pheno
Applicant	SIEMENS MEDICAL SOLUTION USA, INC. 40 LIBERTY BOULEVARD 65-1A MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	PATRICIA D. JONES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2016
Decision Date	03/09/2017
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