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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact