FDA 510(k) Application Details - K012227

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K012227
Device Name Accelerator, Linear, Medical
Applicant ONCOLOGY DATA SYSTEMS, INC.
12401 S. RIVERVIEW RD.
OKLAHOMA CITY, OK 73173 US
Other 510(k) Applications for this Company
Contact GREGORY G MILLER
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 07/16/2001
Decision Date 10/01/2001
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