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510(k) K033470

SIMULIX EVOLUTION by Nucletron Corporation — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2004
Date Received
November 3, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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Other clearances for product code KPQ

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  • 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)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)