FDA 510(k) Application Details - K211379

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K211379
Device Name System,Planning,Radiation Therapy Treatment
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 892.5050

  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 05/04/2021
Decision Date 07/30/2021
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