Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWB — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
220 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® ( | Elekta Solutions AB | 2025-07-02 | 140 | 1 |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024-02-08 | 146 | 0 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Lek | Elekta Solutions AB | 2022-10-26 | 106 | 0 |
| K203250 | TaiChiC | Our United Corporation | 2021-03-12 | 128 | 0 |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | 2021-03-05 | 135 | 0 |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020-02-04 | 25 | 0 |
| K190844 | Akesis Galaxy | Akesis, Inc. | 2019-09-04 | 156 | 0 |
| K180571 | GammaPod | Xcision Medical Systems, LLC | 2018-04-04 | 30 | 1 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018-03-30 | 106 | 0 |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018-02-09 | 57 | 1 |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017-12-22 | 106 | 1 |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-04-20 | 63 | 1 |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015-10-29 | 181 | 0 |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015-08-04 | 55 | 0 |
| K150191 | GammaBeam 500 | Best Theratronics Limited | 2015-04-17 | 79 | 0 |
| K142219 | GammaBeam 100 | Best Theratronics Limited | 2014-11-13 | 93 | 0 |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2014-05-09 | 170 | 0 |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | 2014-02-28 | 256 | 0 |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2012-05-24 | 69 | 1 |
| K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | Masep Medical Science & Tech.Development (Shenzhen | 2011-03-22 | 200 | 0 |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Elekta Instrument AB | 2009-09-22 | 75 | 1 |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2007-03-05 | 105 | 4 |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | Elekta Instrument AB | 2006-08-21 | 42 | 0 |
| K061540 | LEKSELL GAMMAPLAN | Elekta Instrument AB | 2006-07-05 | 30 | 0 |
| K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | American Radiosurgery, Inc. | 2006-04-06 | 57 | 0 |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | Mds Nordion, Inc. | 2006-03-09 | 84 | 0 |
| K051022 | GAMMAPLAN | Elekta Instrument AB | 2005-06-01 | 40 | 0 |
| K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM | Masep Med Science & Tech. Development (Shenzhen) C | 2004-12-30 | 244 | 0 |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | Mds Nordion | 2000-04-27 | 29 | 2 |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTH | Accuray, Inc. | 2000-04-19 | 65 | 0 |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHE | Accuray, Inc. | 1999-07-14 | 203 | 0 |
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | Elekta Instrument AB | 1999-05-21 | 169 | 4 |
| K983917 | THERATRON ELITE | Theratronics, Inc. | 1998-12-04 | 30 | 2 |
| K973441 | LEKSELL GAMMAPLAN | Patterson Consulting Group, Inc. | 1998-04-01 | 202 | 4 |
| K964606 | THERATRON 780E | Theratronics, Inc. | 1997-06-26 | 220 | 1 |
| K970647 | OUR ROTATING GAMMA SYSTEM | Our Scientific Intl., Inc. | 1997-05-20 | 89 | 0 |
| K960892 | THE COBALT SCALPEL | Nova Therapeutic System | 1996-06-03 | 90 | 0 |
| K924849 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. | Elekta Radiosurgery, Inc. | 1995-11-20 | 1148 | 0 |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Scanditronix, Inc. | 1993-01-04 | 83 | 0 |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Elekta Instruments, Inc. | 1992-01-23 | 90 | 0 |
| K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES | Theta Systems, Inc. | 1991-11-05 | 168 | 0 |
| K894165 | THERATRON 1000 | Theratronics, Inc. | 1990-02-01 | 230 | 0 |
| K871215 | DISPOSABLE SHADOW TRAY INSERTS | Mick Radio-Nuclear Instruments, Inc. | 1987-04-06 | 11 | 0 |
| K863180 | THERATRON-PHOENIX | Aecl Medical | 1986-10-27 | 70 | 1 |
| K860849 | MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM | Marx Pland | 1986-04-08 | 33 | 0 |
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | Atomic Energy of Canada | 1985-05-10 | 88 | 0 |
| K827583 | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE | Nucletronix, Inc. | 1982-09-29 | 30 | 0 |
| K780948 | SYSTEM, PLANNING, TREATMENT | Emi Therapy Systems, Inc. | 1978-06-22 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda