KPQ · System, Simulation, Radiation Therapy
Radiology · 21 CFR 892.5840 · Class 2
Overview
| Product Code | KPQ |
|---|---|
| Device Name | System, Simulation, Radiation Therapy |
| Regulation | 21 CFR 892.5840 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II.
Cleared Devices (70)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | Mar 14, 2014 | SESE |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Ge Hungary Kft | Sep 4, 2013 | SESE |
| K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | Acceletronics Digital Imaging, LLC | Aug 17, 2010 | SESE |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | Jun 15, 2009 | SESE |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | Dec 29, 2008 | SESE |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | Sep 14, 2007 | SESE |
| K061006 | IKOENGELO | Ikoetech, LLC | Jun 5, 2006 | SESE |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | Oct 24, 2005 | SESE |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | Sep 14, 2005 | SESE |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | Feb 4, 2004 | SESE |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | Dec 30, 2003 | SESE |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | Sep 25, 2003 | SESE |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | Oct 11, 2002 | SESE |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | Oct 7, 2002 | SESE |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | Jul 29, 2002 | SESE |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | Nov 7, 2001 | SESE |
| K992751 | SOMAVISION | Varian Assoc., Inc. | Feb 16, 2000 | SESE |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | Nov 4, 1998 | SESE |
| K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT | Nucletron Corp. | Jan 22, 1998 | SESE |
| K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM | Varian Medical Systems, Inc. | Aug 15, 1997 | SESE |
| K964972 | SHADOWFORM | I.Z.I. Medical Products Corp. | May 5, 1997 | SESE |
| K964138 | VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE | Varian Medical Systems, Inc. | Jan 10, 1997 | SESE |
| K953233 | SIMVIEW 3000 CT OPTION | Siemens Medical Solutions USA, Inc. | Nov 29, 1996 | SESE |
| K960737 | MODEL 555 010 XY CONVERSION(55010) | Systems Supply Services, Inc. | May 22, 1996 | SESE |
| K951830 | ADVANTAGE SIM | General Electric Co. | Nov 13, 1995 | SESE |
| K945838 | CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY | Toshiba America Medical Systems, In.C | Oct 25, 1995 | SESE |
| K946128 | SIMULIX-HP | Oldelft Corp. of America | May 12, 1995 | SESE |
| K946053 | SIMVIEW(TM) 3000 | Siemens Medical Solutions USA, Inc. | Mar 31, 1995 | SESE |
| K930213 | MODEL ASYM-100 | Nucletron Mfg. Corp. | Sep 7, 1993 | SESE |
| K921108 | CMS RECORD AND VERIFY | Computerized Medical Systems, Inc. | Nov 2, 1992 | SESE |
| K923851 | ACQSIM SIMULATOR/LOCALIZER | Philips Medical Systems (Cleveland), Inc. | Oct 27, 1992 | SESE |
| K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS | I.Z.I. Corp. | Oct 16, 1992 | SESE |
| K920506 | CONTOURING DEVICE | X-Icon Medical Systems | Oct 14, 1992 | SESE |
| K921876 | MKS BEAM OUTLINE PROJECTOR | Medical Knowledge Systems, Inc. | Jun 25, 1992 | SESE |
| K914926 | SCANDIPLAN - VERSION 338 | Scanditronix, Inc. | May 28, 1992 | SESE |
| K913017 | MODULEX RTP SYSTEM | Computerized Medical Systems, Inc. | Oct 17, 1991 | SESE |
| K903313 | RAHD 3100 | Esm , Ltd. | Oct 7, 1991 | SESE |
| K910647 | XIMATRON/CT OPTION | Fischer Imaging Corp. | Sep 19, 1991 | SESE |
| K911340 | AUTOCOMP | Victoreen, Inc. | Aug 26, 1991 | SESE |
| K912466 | OLDELFT SIMULIX-MC | Oldelft Corp. of America | Jun 28, 1991 | SESE |
| K910367 | COMPUTE-RX-COMP (TM) | Medicalibration Physics Consultant Services, Inc. | May 30, 1991 | SESE |
| K896555 | CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT | W. L. Systems, Inc. | Apr 26, 1990 | SESE |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | Advanced Medical Systems, Inc. | Jan 9, 1990 | SESE |
| K896353 | GE TARGET SERIES 2 | GE Medical Systems | Dec 22, 1989 | SESE |
| K895442 | THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL | Altek Corp. | Dec 14, 1989 | SESE |
| K884261 | PROWESS 2000 | Small Systems Group, Inc. | Aug 4, 1989 | SESE |
| K891293 | SLS SIMULATOR (MODELS SLS-9 AND SLS-14) | Philips Medical Systems North America, Inc. | Apr 20, 1989 | SESE |
| K884323 | XIMAVIEW(TM) | Varian Assoc., Inc. | Apr 3, 1989 | SESE |
| K885081 | SIMRITE VERIFICATION AND SIMULATION SYSTEM | Haynes Radiation Ltd., Inc. | Mar 22, 1989 | SESE |
| K873580 | MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR | Medical High Technology International, Inc. | Nov 2, 1987 | SESE |
| K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) | Kermath Mfg. Corp. | May 12, 1987 | SESE |
| K854880 | RADIATION BEAM DATA ACQUISTIOIN SYSTEMS | Computerized Medical Systems, Inc. | Jan 10, 1986 | SESE |
| K853671 | BEAMSCAN | Victoreen, Inc. | Jan 10, 1986 | SESE |
| K853349 | VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST | Varian Assoc., Inc. | Oct 28, 1985 | SESE |
| K852410 | MEVAPLAN AND SOMADOS | Siemens Medical Solutions USA, Inc. | Oct 28, 1985 | SESE |
| K851813 | THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE | Victoreen, Inc. | Aug 7, 1985 | SESE |
| K850977 | COMPUTE RX-PLAN | Medicalibration | Jul 26, 1985 | SESE |
| K851653 | VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP | Varian Assoc., Inc. | May 23, 1985 | SESE |
| K834281 | RAD II SIMULATOR | Haynes Radiation Ltd., Inc. | Dec 29, 1983 | SESE |
| K812726 | KERMATH THERAPY SIMULATOR | Kermath Mfg. Corp. | Nov 5, 1981 | SESE |
| K810858 | XIMATRON V | Siemens Corp. | May 13, 1981 | SESE |
| K803124 | SIDOS U. | Siemens Corp. | Jan 22, 1981 | SESE |
| K803032 | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. | Pfizer Medical Systems, Inc. | Jan 22, 1981 | SESE |
| K782005 | RADIATION ONCOLOGY SYSTEM | Adac Laboratories | Dec 20, 1978 | SESE |
| K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE | Emi Medical, Inc. | Sep 14, 1978 | SESE |
| K781496 | XIMATRON IV | Siemens Elema AB | Sep 14, 1978 | SESE |
| K780963 | X-RAY SYSTEM | General X-Ray, Inc. | Jun 27, 1978 | SESE |
| K770202 | CTM (CLINAC TREATMENT MONITOR) | Varian Assoc., Inc. | Feb 7, 1977 | SESE |
| K761265 | VARIPLAN COMPUT. RADIOTHERAPY | Varian Assoc., Inc. | Dec 21, 1976 | SESE |
| K760420 | FILTER, VACUUM LINE LINEGUARD | Diemolding Corp. | Aug 23, 1976 | SESE |
Top Applicants
- Varian Assoc., Inc. — 6 clearances
- Varian Medical Systems, Inc. — 4 clearances
- Victoreen, Inc. — 3 clearances
- Siemens Medical Solutions USA, Inc. — 3 clearances
- Nucletron Corporation — 3 clearances
