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510(k) K010682

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM by Mds Nordion — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2001
Date Received
March 7, 2001
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

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