Home / 510(k) Clearances / K132045

510(k) K132045

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS by Ge Hungary Kft — Product Code KPQ

K132045 is an FDA 510(k) premarket notification submitted by Ge Hungary Kft for the device "ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS". The FDA issued a decision of Substantially Equivalent on September 4, 2013. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Ge Hungary Kft has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2013
Date Received
July 2, 2013
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 Ge Hungary Kft

  • K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (March 14, 2014)

Other clearances for product code KPQ

  • K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (March 14, 2014)
  • 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)
  • K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (December 30, 2003)

FDA data resources