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510(k) K181789

VeriSuite by Medcom GmbH — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2018
Date Received
July 5, 2018
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

  • K180308 — Prelude (March 27, 2018)
  • K170841 — BiopSee, Mobile US (July 26, 2017)
  • K163119 — NaviSuite SSI Edition (May 1, 2017)
  • 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)
  • 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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  • K201798 — myQA iON (July 17, 2020)
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