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510(k) K133914

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
December 23, 2013
Clearance Type
Abbreviated
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

Other clearances by Medcom GmbH

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  • K170841 — BiopSee, Mobile US (July 26, 2017)
  • K163119 — NaviSuite SSI Edition (May 1, 2017)
  • K102237 — PVS MODEL 1.0 (November 23, 2010)
  • K100056 — MEDCOM RT-VIEWER SYSTEM (May 7, 2010)
  • K092653 — VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 (September 18, 2009)
  • 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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