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510(k) K092653

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 by Medcom GmbH — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2009
Date Received
August 28, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K133914 — VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE (April 3, 2014)
  • K102237 — PVS MODEL 1.0 (November 23, 2010)
  • K100056 — MEDCOM RT-VIEWER SYSTEM (May 7, 2010)
  • 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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