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510(k) K946128

SIMULIX-HP by Oldelft Corp. of America — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
December 15, 1994
Clearance Type
Traditional
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 Oldelft Corp. of America

  • K980296 — OLDELFT DIGIDELCA (April 17, 1998)
  • K973219 — AMBER DU (October 8, 1997)
  • K950037 — N 800 HF (February 15, 1995)
  • K932848 — SIMULIX-MC CT EXTENSION (March 22, 1994)
  • K923584 — THERAPAX DXT 300 SERIES 3 (January 15, 1993)
  • K914784 — PAPILLION PROCTOSCOPE (June 5, 1992)
  • K912466 — OLDELFT SIMULIX-MC (June 28, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

Other clearances for product code KPQ

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  • 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)