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510(k) K993766

HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM by Helax AB — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1999
Date Received
November 8, 1999
Clearance Type
Special
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

Other clearances by Helax AB

  • K982857 — HELAX-IMCON, VERSION 1.0 (November 4, 1998)
  • K972617 — HELAX-VISIR (October 1, 1997)

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