510(k) K925133

DPD-510 THERAPEUTIC RADIATION DOSIMETER by Scanditronix, Inc. — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1993
Date Received
October 13, 1992
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