System, Simulation, Radiation Therapy

Product Code: KPQ

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.5840


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as KPQ

5368System, Simulation, Radiation TherapyRadiation Therapy Simulation System.

Total Product Life Cycle (TPLC) Devices

5368System, Simulation, Radiation TherapyRadiation Therapy Simulation System.

FDA Consensus Standards

System, Simulation, Radiation Therapy [32082]21 CFR §892.5840 🔎
System, Simulation, Radiation Therapy [31241]21 CFR §892.5840 🔎
System, Simulation, Radiation Therapy [32087]21 CFR §892.5840 🔎

Pre-market Notifications for KPQ

K132944ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATIONGE HUNGARY KFT
K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGE HUNGARY KFT
K101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERACCELETRONICS DIGITAL IMAGING, LLC.
K090706ONCENTRA SIMULATION 2.3NUCLETRON CORPORATION
K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNUCLETRON CORP.
K061006IKOENGELOIKOETECH, LLC.
K052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNUCLETRON CORPORATION
K052345ADVANTAGE SIM MDGE HEALTHCARE
K033470SIMULIX EVOLUTIONNUCLETRON CORPORATION
K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYVARIAN MEDICAL SYSTEMS, INC.
K032550EXOMIO, MODEL 2.0 SP1MEDCOM GMBH
K023052ACUITY RADIATION THERAPY SIMULATORVARIAN MEDICAL SYSTEMS, INC.
K022219EXOMIO, MODEL 1.1MEDCOM GMBH
K021780ADVANTAGE SIM 6.0GENERAL ELECTRIC MEDICAL SYSTEMS
K992751SOMAVISIONVARIAN ASSOC., INC.

Global Unique Device Identification Database

00815212022142System, Simulation, Radiation Therapy
00815212022135System, Simulation, Radiation Therapy
00815212022128System, Simulation, Radiation Therapy
00815212022111System, Simulation, Radiation Therapy
00815212022074System, Simulation, Radiation Therapy
00815212022067System, Simulation, Radiation Therapy
00815212022050System, Simulation, Radiation Therapy
00815212022012System, Simulation, Radiation Therapy
00815212021749System, Simulation, Radiation Therapy
00815212021732System, Simulation, Radiation Therapy
00815212021725System, Simulation, Radiation Therapy
00815212021718System, Simulation, Radiation Therapy
00815212021701System, Simulation, Radiation Therapy
00815212021695System, Simulation, Radiation Therapy
07540180000207System, simulation, radiation therapy

Maude Adverse Events

DRUG/BIOLOGIC RADIATION THERAPYUNKNOWN2020-03-10
SIMVIEW NTSIEMENS HEALTHCARE GMBH2019-09-23
RADIATION2014-11-13
RADIATION2014-11-13
ACUITYVARIAN MEDICAL SYSTEMS2014-03-19
SIMVIEW NT WITH IDISIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY2013-09-25
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC.2012-11-16
ACUITYVARIAN MEDICAL SYSTEMS2012-09-27
SIMVIEW 3000 SIMULATORSIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY2012-01-19
XKNIFE 5.0 INSTALL KITINTEGRA BURLINGTON, MA, INC2011-12-06
ONCENTRA SIMULATIONNUCLETRON BV2011-10-05
XKNIFE 5.0 INSTALL KITINTEGRA, BURLINGTON2011-08-18
ACUITYVARIAN MEDICAL SYSTEMS UK LTD.2011-07-26
ACUITYVARIAN MEDICAL SYSTEMS UK LTD.2011-07-26
ACUITYVARIAN MEDICAL SYSTEMS UK LTD.2011-07-20
ACUITYVARIAN MEDICAL SYSTEMS UK LTD2011-07-14
ACUITYVARIAN MEDICAL SYSTEMS UK LTD.2011-05-20
ACUITYVARIAN MEDICAL2011-03-30
SMX/GENERALNUCLETRON BV2011-02-28
ACUITYVARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS2011-01-28
XIMATRON C RADIOTHERAPY TREATMENT SIMULATORVARIAN MEDICAL SYSTEMS UK LTD2011-01-06
ACUITYVARIAN MEDICAL SYSTEMS2010-10-21
SIEMENS BRAND NAME: SIMVIEW NTSIEMENS MEDICAL SOLUTIONS USA, INC.2010-08-31
ACUITYVARIAN MEDICAL SYSTEMS2010-08-10
ACUITYVARIAN MEDICAL SYSTEMS2010-08-02
ACUITYVARIAN MEDICAL SYSTEMS2010-07-14
XKNIFE RT LINUX WORKSTATIONINTEGRA RADIONICS2010-05-20
XIMATRONVARIAN MEDICAL SYSTEMS2010-04-13
ACUITYVARIAN MEDICAL SYSTEMS2010-03-03
ACUITYVARIAN MEDICAL SYSTEMS2010-03-03
ACUITYVARIAN MEDICAL SYSTEMS2010-02-25
XIMATRONVARIAN MEDICAL SYSTEMS2009-12-22
VARIANVARIAN2009-11-30
ACUITYVARIAN MEDICAL SYSTEMS2009-09-28
SIEMENS BRAND NAME: SIMVIEW 3000SIEMENS MEDICAL SOLUTIONS USA, INC.2009-06-19
FOCALCMS INC2009-02-11
FOCALCMS INC2009-02-11
SIMVIEW THERAPY SIMULATORSIEMENS MEDICAL SOLUTIONS USA, INC.2009-01-28
AW ADVANTAGE SIM MDGE MEDICAL SYSTEMS S.C.S2008-12-16
INTERPLANT PROSTATE BRACHYTHERAPY RTP SYSTEMCMS INC.2008-11-18
ACUITYVARIAN MEDICAL SYSTEMS2008-10-29
ACUITYVARIAN MEDICAL SYSTEMS2008-08-11
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