IWB · System, Radiation Therapy, Radionuclide
Radiology · 21 CFR 892.5750 · Class 2
Overview
| Product Code | IWB |
|---|---|
| Device Name | System, Radiation Therapy, Radionuclide |
| Regulation | 21 CFR 892.5750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.
Classification Rationale
Class II.
Cleared Devices (48)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB | Jul 2, 2025 | SESE |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | Feb 8, 2024 | SESE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | Oct 26, 2022 | SESE |
| K203250 | TaiChiC | Our United Corporation | Mar 12, 2021 | SESE |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | Mar 5, 2021 | SESE |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | Feb 4, 2020 | SESE |
| K190844 | Akesis Galaxy | Akesis, Inc. | Sep 4, 2019 | SESE |
| K180571 | GammaPod | Xcision Medical Systems, LLC | Apr 4, 2018 | SESE |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | Mar 30, 2018 | SESE |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | Feb 9, 2018 | SESE |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | Dec 22, 2017 | SESE |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | Apr 20, 2016 | SESE |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | Oct 29, 2015 | SESE |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | Aug 4, 2015 | SESE |
| K150191 | GammaBeam 500 | Best Theratronics Limited | Apr 17, 2015 | SESE |
| K142219 | GammaBeam 100 | Best Theratronics Limited | Nov 13, 2014 | SESE |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 9, 2014 | SESE |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | Feb 28, 2014 | SESE |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 24, 2012 | SESE |
| K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | Masep Medical Science & Tech.Development (Shenzhen | Mar 22, 2011 | SESE |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Elekta Instrument AB | Sep 22, 2009 | SESE |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | Mar 5, 2007 | SESE |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | Elekta Instrument AB | Aug 21, 2006 | SESE |
| K061540 | LEKSELL GAMMAPLAN | Elekta Instrument AB | Jul 5, 2006 | SESE |
| K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | American Radiosurgery, Inc. | Apr 6, 2006 | SESE |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | Mds Nordion, Inc. | Mar 9, 2006 | SESE |
| K051022 | GAMMAPLAN | Elekta Instrument AB | Jun 1, 2005 | SESE |
| K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) | Masep Med Science & Tech. Development (Shenzhen) C | Dec 30, 2004 | SESE |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | Mds Nordion | Apr 27, 2000 | SESE |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | Accuray, Inc. | Apr 19, 2000 | SESE |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | Jul 14, 1999 | SESE |
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | Elekta Instrument AB | May 21, 1999 | SESE |
| K983917 | THERATRON ELITE | Theratronics, Inc. | Dec 4, 1998 | SESE |
| K973441 | LEKSELL GAMMAPLAN | Patterson Consulting Group, Inc. | Apr 1, 1998 | SESE |
| K964606 | THERATRON 780E | Theratronics, Inc. | Jun 26, 1997 | SESE |
| K970647 | OUR ROTATING GAMMA SYSTEM | Our Scientific Intl., Inc. | May 20, 1997 | SESE |
| K960892 | THE COBALT SCALPEL | Nova Therapeutic System | Jun 3, 1996 | SESE |
| K924849 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. | Elekta Radiosurgery, Inc. | Nov 20, 1995 | SESE |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Scanditronix, Inc. | Jan 4, 1993 | SESE |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Elekta Instruments, Inc. | Jan 23, 1992 | SESE |
| K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES | Theta Systems, Inc. | Nov 5, 1991 | SESE |
| K894165 | THERATRON 1000 | Theratronics, Inc. | Feb 1, 1990 | SESE |
| K871215 | DISPOSABLE SHADOW TRAY INSERTS | Mick Radio-Nuclear Instruments, Inc. | Apr 6, 1987 | SESE |
| K863180 | THERATRON-PHOENIX | Aecl Medical | Oct 27, 1986 | SESE |
| K860849 | MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM | Marx Pland | Apr 8, 1986 | SESE |
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | Atomic Energy of Canada | May 10, 1985 | SESE |
| K827583 | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE | Nucletronix, Inc. | Sep 29, 1982 | SESE |
| K780948 | SYSTEM, PLANNING, TREATMENT | Emi Therapy Systems, Inc. | Jun 22, 1978 | SESE |
Top Applicants
- Elekta Instrument AB — 13 clearances
- Theratronics, Inc. — 3 clearances
- Elekta Solutions AB — 3 clearances
- Akesis, Inc. — 3 clearances
- Xcision Medical Systems, LLC — 2 clearances
