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510(k) K021780

ADVANTAGE SIM 6.0 by General Electric Medical Systems — Product Code KPQ

K021780 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems for the device "ADVANTAGE SIM 6.0". The FDA issued a decision of Substantially Equivalent on July 29, 2002. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. General Electric Medical Systems has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2002
Date Received
May 30, 2002
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 General Electric Medical Systems

  • K052897 — GE DEFINIUM AMX 700, MODEL AMX 700 (November 8, 2005)
  • K041521 — VOLUME VIEWER PLUS (June 22, 2004)
  • K041270 — CT COLONOGRAPHY II (May 27, 2004)
  • K041267 — CARDIQ ANALYSIS III (May 27, 2004)
  • K014058 — ENTEGRA PE PERSONAL DIGITAL ASSISTANT (December 21, 2001)

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