FDA 510(k) Application Details - K120363

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K120363
Device Name System,Planning,Radiation Therapy Treatment
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD, CA 94520 US
Other 510(k) Applications for this Company
Contact CHRISTINE DUNBAR
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 02/06/2012
Decision Date 03/20/2012
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