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510(k) K100056

MEDCOM RT-VIEWER SYSTEM by Medcom GmbH — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2010
Date Received
January 8, 2010
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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  • K080742 — VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (May 9, 2008)
  • K032550 — EXOMIO, MODEL 2.0 SP1 (September 25, 2003)
  • K022219 — EXOMIO, MODEL 1.1 (October 7, 2002)

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