System, Radiation Therapy, Radionuclide
Regulation 892.5750
0510(k)s in 12 months (48 all time)
1recalls in 12 months (29 all time)
29recalls that name a 510(k)
Top companies in IWB
| Company | 510(k)s | Recalls |
|---|---|---|
| Elekta, Inc. | 0 | 18 |
| Elekta Instrument AB | 13 | 1 |
| MDS Canada Inc. DBA MDS Nordion | 0 | 7 |
| Xcision Medical Systems, LLC | 2 | 2 |
| Akesis, Inc. | 3 | 0 |
| Elekta Solutions AB | 3 | 0 |
| Theratronics, Inc. | 3 | 0 |
| Accuray, Inc. | 2 | 0 |
| Best Theratronics Limited | 2 | 0 |
| Mds Nordion | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2025 | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) Elekta Solutions AB, SE | IWB |
| Feb 8, 2024 | K232854 | Leksell GammaPlan (LGP) Elekta Solutions AB, SE | IWB |
| Oct 26, 2022 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) Elekta Solutions AB, SE | IWB |
| Mar 12, 2021 | K203250 | TaiChiC Our United Corporation, CN | IWB |
| Mar 5, 2021 | K203146 | Akesis Galaxy RTi Akesis, Inc. | IWB |
| Feb 4, 2020 | K200050 | Akesis Galaxy RTx Akesis, Inc. | IWB |
| Sep 4, 2019 | K190844 | Akesis Galaxy Akesis, Inc. | IWB |
| Apr 4, 2018 | K180571 | GammaPod Xcision Medical Systems, LLC | IWB |
| Mar 30, 2018 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| Feb 9, 2018 | K173791 | Leksell GammaPlan Elekta Instrument AB, SE | IWB |
| Dec 22, 2017 | K172706 | GammaPod - Model A Xcision Medical Systems, LLC | IWB |
| Apr 20, 2016 | K160440 | Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| Oct 29, 2015 | K151159 | Leksell Gamma Knife Perfexion Elekta Instrument AB, SE | IWB |
| Aug 4, 2015 | K151561 | Leksell Gamma Knife Icon Elekta Instrument AB, SE | IWB |
| Apr 17, 2015 | K150191 | GammaBeam 500 Best Theratronics Limited, CA | IWB |
| Nov 13, 2014 | K142219 | GammaBeam 100 Best Theratronics Limited, CA | IWB |
| May 9, 2014 | K133565 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| Feb 28, 2014 | K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM Hyper Technology, Inc., CN | IWB |
| May 24, 2012 | K120811 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| Mar 22, 2011 | K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) Masep Medical Science & Tech.Development (Shenzhen | IWB |
| Sep 22, 2009 | K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 Elekta Instrument AB, SE | IWB |
| Mar 5, 2007 | K063512 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, SE | IWB |
| Aug 21, 2006 | K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 Elekta Instrument AB, SE | IWB |
| Jul 5, 2006 | K061540 | LEKSELL GAMMAPLAN Elekta Instrument AB, SE | IWB |
| Apr 6, 2006 | K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 American Radiosurgery, Inc. | IWB |
| Mar 9, 2006 | K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM Mds Nordion, Inc., CA | IWB |
| Jun 1, 2005 | K051022 | GAMMAPLAN Elekta Instrument AB, SE | IWB |
| Dec 30, 2004 | K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) Masep Med Science & Tech. Development (Shenzhen) C | IWB |
| Apr 27, 2000 | K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE Mds Nordion, CA | IWB |
| Apr 19, 2000 | K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 Accuray, Inc. | IWB |
| Jul 14, 1999 | K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. | IWB |
| May 21, 1999 | K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 Elekta Instrument AB | IWB |
| Dec 4, 1998 | K983917 | THERATRON ELITE Theratronics, Inc., CA | IWB |
| Apr 1, 1998 | K973441 | LEKSELL GAMMAPLAN Patterson Consulting Group, Inc. | IWB |
| Jun 26, 1997 | K964606 | THERATRON 780E Theratronics, Inc., CA | IWB |
| May 20, 1997 | K970647 | OUR ROTATING GAMMA SYSTEM Our Scientific Intl., Inc. | IWB |
| Jun 3, 1996 | K960892 | THE COBALT SCALPEL Nova Therapeutic System | IWB |
| Nov 20, 1995 | K924849 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. Elekta Radiosurgery, Inc. | IWB |
| Jan 4, 1993 | K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER Scanditronix, Inc., SE | IWB |
| Jan 23, 1992 | K914808 | LEKSELL GAMMAPLAN (LGP) Elekta Instruments, Inc. | IWB |
| Nov 5, 1991 | K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES Theta Systems, Inc. | IWB |
| Feb 1, 1990 | K894165 | THERATRON 1000 Theratronics, Inc., CA | IWB |
| Apr 6, 1987 | K871215 | DISPOSABLE SHADOW TRAY INSERTS Mick Radio-Nuclear Instruments, Inc. | IWB |
| Oct 27, 1986 | K863180 | THERATRON-PHOENIX Aecl Medical, CA | IWB |
| Apr 8, 1986 | K860849 | MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM Marx Pland | IWB |
| May 10, 1985 | K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY Atomic Energy of Canada, CA | IWB |
| Sep 29, 1982 | K827583 | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE Nucletronix, Inc. | IWB |
| Jun 22, 1978 | K780948 | SYSTEM, PLANNING, TREATMENT Emi Therapy Systems, Inc. | IWB |
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