510(k) K113102

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING by Nucletron — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2011
Date Received
October 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type