FDA 510(k) Applications for Medical Device Product Code "IWB"
(System, Radiation Therapy, Radionuclide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K000478 | ACCURAY, INC. | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | 04/19/2000 |
| K984563 | ACCURAY, INC. | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | 07/14/1999 |
| K190844 | Akesis Inc | Akesis Galaxy | 09/04/2019 |
| K203146 | Akesis Inc | Akesis Galaxy RTi | 03/05/2021 |
| K200050 | Akesis Inc | Akesis Galaxy RTx | 02/04/2020 |
| K060314 | AMERICAN RADIOSURGERY, INC. | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | 04/06/2006 |
| K142219 | Best Theratronics Limited | GammaBeam 100 | 11/13/2014 |
| K150191 | Best Theratronics Limited | GammaBeam 500 | 04/17/2015 |
| K092083 | ELEKTA INSTRUMENT AB | EXTEND FRAME SYSTEM, MODEL 1009633 | 09/22/2009 |
| K051022 | ELEKTA INSTRUMENT AB | GAMMAPLAN | 06/01/2005 |
| K151561 | ELEKTA INSTRUMENT AB | Leksell Gamma Knife Icon | 08/04/2015 |
| K160440 | Elekta Instrument AB | Leksell Gamma Knife Icon | 04/20/2016 |
| K151159 | ELEKTA INSTRUMENT AB | Leksell Gamma Knife Perfexion | 10/29/2015 |
| K120811 | ELEKTA INSTRUMENT AB | LEKSELL GAMMA KNIFE PERFEXION | 05/24/2012 |
| K133565 | ELEKTA INSTRUMENT AB | LEKSELL GAMMA KNIFE PERFEXION | 05/09/2014 |
| K063512 | ELEKTA INSTRUMENT AB | LEKSELL GAMMA KNIFE PERFEXION | 03/05/2007 |
| K173789 | Elekta Instrument AB | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | 03/30/2018 |
| K061941 | ELEKTA INSTRUMENT AB | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | 08/21/2006 |
| K984328 | ELEKTA INSTRUMENT AB | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | 05/21/1999 |
| K173791 | Elekta Instrument AB | Leksell GammaPlan | 02/09/2018 |
| K061540 | ELEKTA INSTRUMENT AB | LEKSELL GAMMAPLAN | 07/05/2006 |
| K222047 | Elekta Solutions AB | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | 10/26/2022 |
| K131777 | HYPER TECHNOLOGY INC | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | 02/28/2014 |
| K041125 | MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) | 12/30/2004 |
| K102533 | MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN | ROTATING GAMMA SYSTEM INFINI (INFINI) | 03/22/2011 |
| K001006 | MDS NORDION | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | 04/27/2000 |
| K053485 | MDS NORDION INC. | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | 03/09/2006 |
| K960892 | NOVA THERAPEUTIC SYSTEM | THE COBALT SCALPEL | 06/03/1996 |
| K970647 | OUR SCIENTIFIC INTL., INC. | OUR ROTATING GAMMA SYSTEM | 05/20/1997 |
| K203250 | Our United Corporation | TaiChiC | 03/12/2021 |
| K973441 | PATTERSON CONSULTING GROUP, INC. | LEKSELL GAMMAPLAN | 04/01/1998 |
| K964606 | THERATRONICS, INC. | THERATRON 780E | 06/26/1997 |
| K983917 | THERATRONICS, INC. | THERATRON ELITE | 12/04/1998 |
| K180571 | Xcision Medical Systems, LLC | GammaPod | 04/04/2018 |
| K172706 | Xcision Medical Systems, LLC | GammaPod - Model A | 12/22/2017 |
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