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510(k) K083591

Device
IKOENGELO, VERSION 2
Applicant
Ikoetech, LLC
510(k) number
K083591
Product code
KPQ
Decision
Substantially Equivalent (SESE)
Decision date
2008-12-29
Date received
2008-12-04
Regulation
892.5840
Classification name
System, Simulation, Radiation Therapy
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HUIMIN CHAO
Address
6223 Richmond Ave., Suite 303 Houston TX US 77057 77057

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132944ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATIONGe Hungary Kft2014-03-14
K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary Kft2013-09-04
K101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLC2010-08-17
K090706ONCENTRA SIMULATION 2.3Nucletron Corporation2009-06-15
K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.2007-09-14
K061006IKOENGELOIkoetech, LLC2006-06-05
K052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNucletron Corporation2005-10-24
K052345ADVANTAGE SIM MDGE Healthcare2005-09-14
K033470SIMULIX EVOLUTIONNucletron Corporation2004-02-04
K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYVarian Medical Systems, Inc.2003-12-30
K032550EXOMIO, MODEL 2.0 SP1Medcom GmbH2003-09-25
K023052ACUITY RADIATION THERAPY SIMULATORVarian Medical Systems, Inc.2002-10-11
K022219EXOMIO, MODEL 1.1Medcom GmbH2002-10-07
K021780ADVANTAGE SIM 6.0General Electric Medical Systems2002-07-29
K013531QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00Impac Medical Systems, Inc.2001-11-07