Home / 510(k) Clearances / K013531

510(k) K013531

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 by Impac Medical Systems, Inc. — Product Code KPQ

K013531 is an FDA 510(k) premarket notification submitted by Impac Medical Systems, Inc. for the device "QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00". The FDA issued a decision of Substantially Equivalent on November 7, 2001. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Impac Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2001
Date Received
October 23, 2001
Clearance Type
Traditional
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 Impac Medical Systems, Inc.

  • K151233 — Monaco (July 7, 2015)
  • K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (September 5, 2014)
  • K132971 — MONACO (November 20, 2013)
  • K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (December 12, 2012)
  • K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM (February 28, 2012)
  • K043412 — MODIFICATION TO: VIEWSTATION (December 20, 2004)
  • K011694 — VIEWSTATION (August 29, 2001)
  • K991133 — MLC FIT (March 27, 2000)
  • K981313 — SEQUENCER (July 9, 1998)
  • K962335 — MLC FIT (February 6, 1997)

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