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510(k) K914926

SCANDIPLAN - VERSION 338 by Scanditronix, Inc. — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
November 4, 1991
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 Scanditronix, Inc.

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  • K942092 — DPD-3 (July 29, 1994)
  • K925133 — DPD-510 THERAPEUTIC RADIATION DOSIMETER (January 4, 1993)
  • K904753 — DIOLASE (November 9, 1990)
  • K900434 — MM-22 MICROTRON, MM50 MICROTRON (October 23, 1990)
  • K843366 — SUPERPETT (November 21, 1984)

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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)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)