Product code KPQ
- Device name
- System, Simulation, Radiation Therapy
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5840
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | 2014-03-14 |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Ge Hungary Kft | 2013-09-04 |
| K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | Acceletronics Digital Imaging, LLC | 2010-08-17 |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | 2009-06-15 |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | 2008-12-29 |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | 2007-09-14 |
| K061006 | IKOENGELO | Ikoetech, LLC | 2006-06-05 |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | 2005-10-24 |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | 2005-09-14 |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | 2004-02-04 |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | 2003-12-30 |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | 2003-09-25 |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | 2002-10-11 |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | 2002-10-07 |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | 2002-07-29 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | 2001-11-07 |
| K992751 | SOMAVISION | Varian Assoc., Inc. | 2000-02-16 |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | 1998-11-04 |
| K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT | Nucletron Corp. | 1998-01-22 |
| K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM | Varian Medical Systems, Inc. | 1997-08-15 |
| K964972 | SHADOWFORM | I.Z.I. Medical Products Corp. | 1997-05-05 |
| K964138 | VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE | Varian Medical Systems, Inc. | 1997-01-10 |
| K953233 | SIMVIEW 3000 CT OPTION | Siemens Medical Solutions USA, Inc. | 1996-11-29 |
| K960737 | MODEL 555 010 XY CONVERSION(55010) | Systems Supply Services, Inc. | 1996-05-22 |
| K951830 | ADVANTAGE SIM | General Electric Co. | 1995-11-13 |
| K945838 | CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY | Toshiba America Medical Systems, In.C | 1995-10-25 |
| K946128 | SIMULIX-HP | Oldelft Corp. of America | 1995-05-12 |
| K946053 | SIMVIEW(TM) 3000 | Siemens Medical Solutions USA, Inc. | 1995-03-31 |
| K930213 | MODEL ASYM-100 | Nucletron Mfg. Corp. | 1993-09-07 |
| K921108 | CMS RECORD AND VERIFY | Computerized Medical Systems, Inc. | 1992-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00856545006003 | Acuity iX Radiation Therapy Simulation System | VARIAN MEDICAL SYSTEMS, INC. | 2020-09-20 |
| 07540180000238 | Clarity® | Elekta Solutions AB | 2020-06-19 |
| 00856545006010 | Varian Acuity with Conebeam Computed Tomography | VARIAN MEDICAL SYSTEMS, INC. | 2020-06-04 |
| 07540180000221 | Clarity® | Elekta Solutions AB | 2020-05-22 |
| 07540180000214 | Clarity® | Elekta Solutions AB | 2019-03-27 |
| 07540180000207 | Clarity® | Elekta Ltd | 2018-11-19 |
| 07540180000184 | Clarity® | Elekta Ltd | 2017-01-10 |
| 00815212021749 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 00815212021732 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 00815212021725 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 00815212021718 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 00815212021701 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 00815212021695 | ShadowForm Marker | Izi Medical Products, LLC | 2016-11-17 |
| 07540180000177 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000016 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000030 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000047 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000054 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000078 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000085 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000092 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000115 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000153 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000160 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000108 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000061 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000023 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000122 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000139 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000146 | Clarity® | Elekta Solutions AB | 2016-09-23 |