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510(k) K946128

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

K946128 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "SIMULIX-HP". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.

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

  • 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