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510(k) K052361

SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM by Nucletron Corporation — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2005
Date Received
August 29, 2005
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)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)