FDA 510(k) Application Details - K082606

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K082606
Device Name System,Planning,Radiation Therapy Treatment
Applicant D3 RADIATION PLANNING
5750 CENTRE AVE., SUITE 500
PUTTSBURGH, PA 15206 US
Other 510(k) Applications for this Company
Contact NABIL ADNANI
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 09/08/2008
Decision Date 11/10/2008
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