System, Simulation, Radiation Therapy
FDA product code KPQ · Class II (moderate risk) · 21 CFR 892.5840 · Radiology
70510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Varian Assoc., Inc. 6
- Nucletron Corp. 5
- Varian Medical Systems, Inc. 4
- Computerized Medical Systems Inc 3
- Siemens Medical Solutions USA, Inc. 3
- Victoreen, Inc. 3
- Oldelft Corp. of America 2
- Ikoetech, LLC 2
- Ge Hungary Kft 2
- Haynes Radiation Ltd., Inc. 2
- Kermath Mfg. Corp. 2
- Siemens Corp. 2
- Medcom GmbH 2
- Medicalibration 1
- Adac Laboratories 1
- Emi Medical, Inc. 1
- Siemens Elema AB 1
- Altek Corp. 1
- GE Medical Systems, LLC 1
- General X-Ray, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132944 | Advantagesim MD MR Pelvic Organ at Risk SegmentationKPQ · Traditional | Ge Hungary Kft | 03/14/2014SE |
| K132045 | Advantagesim MD with CT Atlas-Based Contouring and Re-Planning OptionsKPQ · Traditional | Ge Hungary Kft | 09/04/2013SE |
| K101038 | Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerKPQ · Traditional | Acceletronics Digital Imaging, LLC | 08/17/2010SE |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | Nucletron Corporation | 06/15/2009SE |
| K083591 | Ikoengelo, Version 2KPQ · Special | Ikoetech, LLC | 12/29/2008SE |
| K072445 | Integrated Brachytherapy Unit - DigitalKPQ · Special | Nucletron Corp. | 09/14/2007SE |
| K061006 | IkoengeloKPQ · Traditional | Ikoetech, LLC | 06/05/2006SE |
| K052361 | Simulix-Evolution with Oncentra ConebeamKPQ · Special | Nucletron Corporation | 10/24/2005SE |
| K052345 | Advantage Sim MDKPQ · Traditional | GE Healthcare | 09/14/2005SE |
| K033470 | Simulix EvolutionKPQ · Special | Nucletron Corporation | 02/04/2004SE |
| K033339 | Acuity with Conebeam Computed TomographyKPQ · Traditional | Varian Medical Systems, Inc. | 12/30/2003SE |
| K032550 | Exomio, Model 2.0 SP1KPQ · Special | Medcom GmbH | 09/25/2003SE |
| K023052 | Acuity Radiation Therapy SimulatorKPQ · Special | Varian Medical Systems, Inc. | 10/11/2002SE |
| K022219 | Exomio, Model 1.1KPQ · Traditional | Medcom GmbH | 10/07/2002SE |
| K021780 | Advantage Sim 6.0KPQ · Traditional | General Electric Medical Systems | 07/29/2002SE |
| K013531 | Qwiksim Virtual Simulation System; Version 2.00KPQ · Traditional | Impac Medical Systems, Inc. | 11/07/2001SE |
| K992751 | SomavisionKPQ · Traditional | Varian Assoc., Inc. | 02/16/2000SE |
| K982857 | Helax-Imcon, Version 1.0KPQ · Traditional | Helax AB | 11/04/1998SE |
| K973848 | Ibu, Integrated Brachy Therapy UnitKPQ · Traditional | Nucletron Corp. | 01/22/1998SE |
| K971839 | Varian Radiation Therapy Imaging SystemKPQ · Traditional | Varian Medical Systems, Inc. | 08/15/1997SE |
| K964972 | ShadowformKPQ · Traditional | I.Z.I. Medical Products Corp. | 05/05/1997SE |
| K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 SoftwareKPQ · Traditional | Varian Medical Systems, Inc. | 01/10/1997SE |
| K953233 | Simview 3000 CT OptionKPQ · Traditional | Siemens Medical Solutions USA, Inc. | 11/29/1996SE |
| K960737 | Model 555 010 Xy CONVERSION(55010)KPQ · Traditional | Systems Supply Services, Inc. | 05/22/1996SE |
| K951830 | Advantage SimKPQ · Traditional | General Electric Co. | 11/13/1995SE |
| K945838 | Ctport CT Simulation System for RadiotherapyKPQ · Traditional | Toshiba America Medical Systems, In.C | 10/25/1995SE |
| K946128 | Simulix-HpKPQ · Traditional | Oldelft Corp. of America | 05/12/1995SE |
| K946053 | Simview(Tm) 3000KPQ · Traditional | Siemens Medical Solutions USA, Inc. | 03/31/1995SE |
| K930213 | Model ASYM-100KPQ · Traditional | Nucletron Mfg. Corp. | 09/07/1993SE |
| K921108 | CMS Record and VerifyKPQ · Traditional | Computerized Medical Systems, Inc. | 11/02/1992SE |
| K923851 | Acqsim Simulator/LocalizerKPQ · Traditional | Philips Medical Systems (Cleveland), Inc. | 10/27/1992SE |
| K922287 | E.Z. Port(Tm) Radiation Therapy Skin MarkersKPQ · Traditional | I.Z.I. Corp. | 10/16/1992SE |
| K920506 | Contouring DeviceKPQ · Traditional | X-Icon Medical Systems | 10/14/1992SE |
| K921876 | MKS Beam Outline ProjectorKPQ · Traditional | Medical Knowledge Systems, Inc. | 06/25/1992SE |
| K914926 | Scandiplan - Version 338KPQ · Traditional | Scanditronix, Inc. | 05/28/1992SE |
| K913017 | Modulex RTP SystemKPQ · Traditional | Computerized Medical Systems, Inc. | 10/17/1991SE |
| K903313 | Rahd 3100KPQ · Traditional | Esm , Ltd. | 10/07/1991SE |
| K910647 | Ximatron/Ct OptionKPQ · Traditional | Fischer Imaging Corp. | 09/19/1991SE |
| K911340 | AutocompKPQ · Traditional | Victoreen, Inc. | 08/26/1991SE |
| K912466 | Oldelft Simulix-McKPQ · Traditional | Oldelft Corp. of America | 06/28/1991SE |
| K910367 | Compute-Rx-Comp (TM)KPQ · Traditional | Medicalibration Physics Consultant Services, Inc. | 05/30/1991SE |
| K896555 | CTS Computed Tomography (CT) AttachmentKPQ · Traditional | W. L. Systems, Inc. | 04/26/1990SE |
| K894568 | New RAD-8 Treatment Planning Computer SystemKPQ · Traditional | Advanced Medical Systems, Inc. | 01/09/1990SE |
| K896353 | GE Target Series 2KPQ · Traditional | GE Medical Systems | 12/22/1989SE |
| K895442 | The X-Ray Digitizer, Altek Model ACT20020-BLKPQ · Traditional | Altek Corp. | 12/14/1989SE |
| K884261 | Prowess 2000KPQ · Traditional | Small Systems Group, Inc. | 08/04/1989SE |
| K891293 | SLS Simulator (Models SLS-9 and SLS-14)KPQ · Traditional | Philips Medical Systems North America, Inc. | 04/20/1989SE |
| K884323 | Ximaview(Tm)KPQ · Traditional | Varian Assoc., Inc. | 04/03/1989SE |
| K885081 | Simrite Verification and Simulation SystemKPQ · Traditional | Haynes Radiation Ltd., Inc. | 03/22/1989SE |
| K873580 | Mhti Ct-Sim Radiation Therapy Treatment SimulatorKPQ · Traditional | Medical High Technology International, Inc. | 11/02/1987SE |
| K870221 | T.O.P. 2000 (Tomographic Orientated Planning)KPQ · Traditional | Kermath Mfg. Corp. | 05/12/1987SE |
| K854880 | Radiation Beam Data Acquistioin SystemsKPQ · Traditional | Computerized Medical Systems, Inc. | 01/10/1986SE |
| K853671 | BeamscanKPQ · Traditional | Victoreen, Inc. | 01/10/1986SE |
| K853349 | Varian Ximatron C-Series Radiotherapy Treatment STKPQ · Traditional | Varian Assoc., Inc. | 10/28/1985SE |
| K852410 | Mevaplan and SomadosKPQ · Traditional | Siemens Medical Solutions USA, Inc. | 10/28/1985SE |
| K851813 | Therpac-Radiation Therapy Treatment Planning SysteKPQ · Traditional | Victoreen, Inc. | 08/07/1985SE |
| K850977 | Compute Rx-PlanKPQ · Traditional | Medicalibration | 07/26/1985SE |
| K851653 | Varian/Ximatron 5 Carbon-Fiber Couch TopKPQ · Traditional | Varian Assoc., Inc. | 05/23/1985SE |
| K834281 | Rad II SimulatorKPQ · Traditional | Haynes Radiation Ltd., Inc. | 12/29/1983SE |
| K812726 | Kermath Therapy SimulatorKPQ · Traditional | Kermath Mfg. Corp. | 11/05/1981SE |
| K810858 | Ximatron VKPQ · Traditional | Siemens Corp. | 05/13/1981SE |
| K803124 | Sidos U.KPQ · Traditional | Siemens Corp. | 01/22/1981SE |
| K803032 | Pfizer Pz-Slm Rad. Therapy Trtmt. Simul.KPQ · Traditional | Pfizer Medical Systems, Inc. | 01/22/1981SE |
| K782005 | Radiation Oncology SystemKPQ · Traditional | Adac Laboratories | 12/20/1978SE |
| K781519 | Emi Simulator Remote Control ConsoleKPQ · Traditional | Emi Medical, Inc. | 09/14/1978SE |
| K781496 | Ximatron IVKPQ · Traditional | Siemens Elema AB | 09/14/1978SE |
| K780963 | X-Ray SystemKPQ · Traditional | General X-Ray, Inc. | 06/27/1978SE |
| K770202 | CTM (Clinac Treatment Monitor)KPQ · Traditional | Varian Assoc., Inc. | 02/07/1977SE |
| K761265 | Variplan Comput. RadiotherapyKPQ · Traditional | Varian Assoc., Inc. | 12/21/1976SE |
| K760420 | Filter, Vacuum Line LineguardKPQ · Traditional | Diemolding Corp. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0235-2015 Class II | Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage:…Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation… | Siemens Medical Solutions USA, Inc | 10/10/2014Terminated |
| Z-0786-2014 Class II | SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview…In a very rare occurrence an intended movement of the SimView NT simulation system components could not be… | Siemens Medical Solutions USA, Inc | 12/11/2013Terminated |
| Z-0754-2013 Class II | AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version…It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series… | GE Healthcare, LLC | 05/24/2012Terminated |
| Z-1718-2009 | AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to…It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series… | GE Medical Systems, LLC | 02/02/2009Terminated |
| Z-0646-2009 | Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT…Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in… | Siemens Medical Solutions USA, Inc | 11/06/2008Terminated |
| Z-2196-2008 | Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and…The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch… | Siemens Medical Solutions USA, Inc | 03/10/2008Terminated |
| Z-1460-2008 | Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model…Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been… | Varian Medical Systems Oncology Systems | 01/03/2008Terminated |
| Z-0213-2008 | Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology…Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an… | Varian Medical Systems Inc | 06/25/2007Terminated |
| Z-0285-2008 | Si emans Evansi, with patient table, Part No: 44 81 586, and without patient table Part…Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding… | Siemens Medical Solutions USA, Inc | 02/27/2007Terminated |
| Z-0284-2008 | Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with…Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding… | Siemens Medical Solutions USA, Inc | 02/27/2007Terminated |
| Z-0283-2008 | Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with…Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding… | Siemens Medical Solutions USA, Inc | 02/27/2007Terminated |
| Z-0282-2008 | Si emans Simiae NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No.…Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding… | Siemens Medical Solutions USA, Inc | 02/27/2007Terminated |
| Z-0281-2008 | Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with…Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding… | Siemens Medical Solutions USA, Inc | 02/27/2007Terminated |