FDA 510(k) Application Details - K123577

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K123577
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DR.
KNOXVILLE, TN 37932 US
Other 510(k) Applications for this Company
Contact ALAINE MEDIO, RAC
Other 510(k) Applications for this Contact
Regulation Number 892.2050

  More FDA Info for this Regulation Number
Classification Product Code LLZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/20/2012
Decision Date 01/22/2013
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



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