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510(k) K020971

DCM 2.0 by Mds Nordion AB — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
March 26, 2002
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

Other clearances by Mds Nordion AB

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  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • 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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