FDA 510(k) Application Details - K990071

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K990071
Device Name System,Planning,Radiation Therapy Treatment
Applicant RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
Other 510(k) Applications for this Company
Contact NANCY C MACDONALD
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 01/11/1999
Decision Date 02/08/1999
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