System, Simulation, Radiation Therapy
Regulation 892.5840
0510(k)s in 12 months (70 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in KPQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 3 | 9 |
| Varian Assoc., Inc. | 6 | 0 |
| Nucletron Corp. | 5 | 0 |
| Varian Medical Systems, Inc. | 4 | 1 |
| Computerized Medical Systems, Inc. | 3 | 0 |
| Victoreen, Inc. | 3 | 0 |
| GE Healthcare | 1 | 1 |
| Ge Hungary Kft | 2 | 0 |
| GE Medical Systems | 1 | 1 |
| Haynes Radiation Ltd., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2014 | K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION Ge Hungary Kft | KPQ |
| Sep 4, 2013 | K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS Ge Hungary Kft | KPQ |
| Aug 17, 2010 | K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER Acceletronics Digital Imaging, LLC | KPQ |
| Jun 15, 2009 | K090706 | ONCENTRA SIMULATION 2.3 Nucletron Corporation | KPQ |
| Dec 29, 2008 | K083591 | IKOENGELO, VERSION 2 Ikoetech, LLC | KPQ |
| Sep 14, 2007 | K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL Nucletron Corp. | KPQ |
| Jun 5, 2006 | K061006 | IKOENGELO Ikoetech, LLC | KPQ |
| Oct 24, 2005 | K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM Nucletron Corporation | KPQ |
| Sep 14, 2005 | K052345 | ADVANTAGE SIM MD GE Healthcare | KPQ |
| Feb 4, 2004 | K033470 | SIMULIX EVOLUTION Nucletron Corporation | KPQ |
| Dec 30, 2003 | K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY Varian Medical Systems, Inc. | KPQ |
| Sep 25, 2003 | K032550 | EXOMIO, MODEL 2.0 SP1 Medcom GmbH, DE | KPQ |
| Oct 11, 2002 | K023052 | ACUITY RADIATION THERAPY SIMULATOR Varian Medical Systems, Inc. | KPQ |
| Oct 7, 2002 | K022219 | EXOMIO, MODEL 1.1 Medcom GmbH, DE | KPQ |
| Jul 29, 2002 | K021780 | ADVANTAGE SIM 6.0 General Electric Medical Systems | KPQ |
| Nov 7, 2001 | K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 Impac Medical Systems, Inc. | KPQ |
| Feb 16, 2000 | K992751 | SOMAVISION Varian Assoc., Inc. | KPQ |
| Nov 4, 1998 | K982857 | HELAX-IMCON, VERSION 1.0 Helax AB, SE | KPQ |
| Jan 22, 1998 | K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT Nucletron Corp. | KPQ |
| Aug 15, 1997 | K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM Varian Medical Systems, Inc. | KPQ |
| May 5, 1997 | K964972 | SHADOWFORM I.Z.I. Medical Products Corp. | KPQ |
| Jan 10, 1997 | K964138 | VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE Varian Medical Systems, Inc., GB | KPQ |
| Nov 29, 1996 | K953233 | SIMVIEW 3000 CT OPTION Siemens Medical Solutions USA, Inc. | KPQ |
| May 22, 1996 | K960737 | MODEL 555 010 XY CONVERSION(55010) Systems Supply Services, Inc. | KPQ |
| Nov 13, 1995 | K951830 | ADVANTAGE SIM General Electric Co. | KPQ |
| Oct 25, 1995 | K945838 | CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY Toshiba America Medical Systems, In.C | KPQ |
| May 12, 1995 | K946128 | SIMULIX-HP Oldelft Corp. of America | KPQ |
| Mar 31, 1995 | K946053 | SIMVIEW(TM) 3000 Siemens Medical Solutions USA, Inc. | KPQ |
| Sep 7, 1993 | K930213 | MODEL ASYM-100 Nucletron Mfg. Corp. | KPQ |
| Nov 2, 1992 | K921108 | CMS RECORD AND VERIFY Computerized Medical Systems, Inc. | KPQ |
| Oct 27, 1992 | K923851 | ACQSIM SIMULATOR/LOCALIZER Philips Medical Systems (Cleveland), Inc. | KPQ |
| Oct 16, 1992 | K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS I.Z.I. Corp. | KPQ |
| Oct 14, 1992 | K920506 | CONTOURING DEVICE X-Icon Medical Systems | KPQ |
| Jun 25, 1992 | K921876 | MKS BEAM OUTLINE PROJECTOR Medical Knowledge Systems, Inc. | KPQ |
| May 28, 1992 | K914926 | SCANDIPLAN - VERSION 338 Scanditronix, Inc. | KPQ |
| Oct 17, 1991 | K913017 | MODULEX RTP SYSTEM Computerized Medical Systems, Inc. | KPQ |
| Oct 7, 1991 | K903313 | RAHD 3100 Esm , Ltd. | KPQ |
| Sep 19, 1991 | K910647 | XIMATRON/CT OPTION Fischer Imaging Corp. | KPQ |
| Aug 26, 1991 | K911340 | AUTOCOMP Victoreen, Inc. | KPQ |
| Jun 28, 1991 | K912466 | OLDELFT SIMULIX-MC Oldelft Corp. of America | KPQ |
| May 30, 1991 | K910367 | COMPUTE-RX-COMP (TM) Medicalibration Physics Consultant Services, Inc. | KPQ |
| Apr 26, 1990 | K896555 | CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT W. L. Systems, Inc. | KPQ |
| Jan 9, 1990 | K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM Advanced Medical Systems, Inc. | KPQ |
| Dec 22, 1989 | K896353 | GE TARGET SERIES 2 GE Medical Systems | KPQ |
| Dec 14, 1989 | K895442 | THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL Altek Corp. | KPQ |
| Aug 4, 1989 | K884261 | PROWESS 2000 Small Systems Group, Inc. | KPQ |
| Apr 20, 1989 | K891293 | SLS SIMULATOR (MODELS SLS-9 AND SLS-14) Philips Medical Systems North America, Inc. | KPQ |
| Apr 3, 1989 | K884323 | XIMAVIEW(TM) Varian Assoc., Inc. | KPQ |
| Mar 22, 1989 | K885081 | SIMRITE VERIFICATION AND SIMULATION SYSTEM Haynes Radiation Ltd., Inc. | KPQ |
| Nov 2, 1987 | K873580 | MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR Medical High Technology International, Inc. | KPQ |
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