FDA Product Code
FDA Product Code IWB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5750
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB | 2025-07-02 | Traditional | PDF ↗ |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024-02-08 | Traditional | PDF ↗ |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | 2022-10-26 | Traditional | PDF ↗ |
| K203250 | TaiChiC | Our United Corporation | 2021-03-12 | Traditional | PDF ↗ |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | 2021-03-05 | Traditional | PDF ↗ |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020-02-04 | Special | PDF ↗ |
| K190844 | Akesis Galaxy | Akesis, Inc. | 2019-09-04 | Traditional | PDF ↗ |
| K180571 | GammaPod | Xcision Medical Systems, LLC | 2018-04-04 | Special | PDF ↗ |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018-03-30 | Traditional | PDF ↗ |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018-02-09 | Traditional | PDF ↗ |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017-12-22 | Traditional | PDF ↗ |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-04-20 | Traditional | PDF ↗ |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015-10-29 | Traditional | PDF ↗ |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015-08-04 | Traditional | PDF ↗ |
| K150191 | GammaBeam 500 | Best Theratronics Limited | 2015-04-17 | Traditional | PDF ↗ |
| K142219 | GammaBeam 100 | Best Theratronics Limited | 2014-11-13 | Special | PDF ↗ |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2014-05-09 | Traditional | PDF ↗ |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2012-05-24 | Traditional | PDF ↗ |
| K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | Masep Medical Science & Tech.Development (Shenzhen | 2011-03-22 | Traditional | PDF ↗ |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Elekta Instrument AB | 2009-09-22 | Traditional | PDF ↗ |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2007-03-05 | Traditional | PDF ↗ |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | Elekta Instrument AB | 2006-08-21 | Traditional | PDF ↗ |
| K061540 | LEKSELL GAMMAPLAN | Elekta Instrument AB | 2006-07-05 | Special | PDF ↗ |
| K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | American Radiosurgery, Inc. | 2006-04-06 | Special | PDF ↗ |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | Mds Nordion, Inc. | 2006-03-09 | Special | PDF ↗ |
| K051022 | GAMMAPLAN | Elekta Instrument AB | 2005-06-01 | Traditional | PDF ↗ |
| K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) | Masep Med Science & Tech. Development (Shenzhen) C | 2004-12-30 | Traditional | PDF ↗ |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | Mds Nordion | 2000-04-27 | Special | PDF ↗ |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | Accuray, Inc. | 2000-04-19 | Special | PDF ↗ |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | Elekta Instrument AB | 1999-05-21 | Traditional | PDF ↗ |
| K983917 | THERATRON ELITE | Theratronics, Inc. | 1998-12-04 | Special | PDF ↗ |
| K973441 | LEKSELL GAMMAPLAN | Patterson Consulting Group, Inc. | 1998-04-01 | Traditional | PDF ↗ |
| K964606 | THERATRON 780E | Theratronics, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K970647 | OUR ROTATING GAMMA SYSTEM | Our Scientific Intl., Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K960892 | THE COBALT SCALPEL | Nova Therapeutic System | 1996-06-03 | Traditional | PDF ↗ |
| K924849 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. | Elekta Radiosurgery, Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Scanditronix, Inc. | 1993-01-04 | Traditional | PDF ↗ |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Elekta Instruments, Inc. | 1992-01-23 | Traditional | PDF ↗ |
| K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES | Theta Systems, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K894165 | THERATRON 1000 | Theratronics, Inc. | 1990-02-01 | Traditional | PDF ↗ |
| K871215 | DISPOSABLE SHADOW TRAY INSERTS | Mick Radio-Nuclear Instruments, Inc. | 1987-04-06 | Traditional | PDF ↗ |
| K863180 | THERATRON-PHOENIX | Aecl Medical | 1986-10-27 | Traditional | PDF ↗ |
| K860849 | MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM | Marx Pland | 1986-04-08 | Traditional | PDF ↗ |
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | Atomic Energy of Canada | 1985-05-10 | Traditional | PDF ↗ |
| K827583 | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE | Nucletronix, Inc. | 1982-09-29 | Traditional | PDF ↗ |
| K780948 | SYSTEM, PLANNING, TREATMENT | Emi Therapy Systems, Inc. | 1978-06-22 | Traditional | PDF ↗ |
Product code IWB · Class II · Radiology. Data: openFDA.