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510(k) K032550

EXOMIO, MODEL 2.0 SP1 by Medcom GmbH — Product Code KPQ

K032550 is an FDA 510(k) premarket notification submitted by Medcom GmbH for the device "EXOMIO, MODEL 2.0 SP1". The FDA issued a decision of Substantially Equivalent on September 25, 2003. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Medcom GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2003
Date Received
August 18, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

Other clearances by Medcom GmbH

  • K181789 — VeriSuite (September 21, 2018)
  • 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)
  • K022219 — EXOMIO, MODEL 1.1 (October 7, 2002)

Other clearances for product code KPQ

  • K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (March 14, 2014)
  • K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (September 4, 2013)
  • K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (August 17, 2010)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K083591 — IKOENGELO, VERSION 2 (December 29, 2008)
  • K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (September 14, 2007)
  • K061006 — IKOENGELO (June 5, 2006)
  • K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (October 24, 2005)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)

FDA data resources