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510(k) K052361

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

K052361 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM". The FDA issued a decision of Substantially Equivalent on October 24, 2005. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Nucletron Corporation has at least 10 other 510(k) clearances on record.

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

Other clearances by Nucletron Corporation

  • K103515 — EQUAL DOSE (September 15, 2011)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL (May 18, 2009)
  • K082642 — ONCENTRA RT VIEWER 1.0 (November 7, 2008)
  • K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT (May 28, 2008)
  • K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (May 20, 2008)
  • K080871 — TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS (April 29, 2008)
  • K080929 — ONCENTRA GYN (April 16, 2008)
  • K073273 — EQUAL DOSE 1.0 (December 11, 2007)
  • K073107 — VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 (December 7, 2007)

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)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)

FDA data resources