510(k) K850543

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY by Atomic Energy of Canada — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1985
Date Received
February 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type