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510(k) K053485

THERATRON EQUINOX, MODELS 80 CM AND 100 CM by Mds Nordion, Inc. — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2006
Date Received
December 15, 2005
Clearance Type
Special
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

Other clearances by Mds Nordion, Inc.

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  • K032684 — RAYCELL (September 26, 2003)
  • K020971 — DCM 2.0 (June 6, 2002)
  • K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (June 5, 2001)
  • K011246 — DCM 1.0 (May 23, 2001)
  • K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (April 27, 2000)

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