Product code IWB
- Device name
- System, Radiation Therapy, Radionuclide
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5750
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | Elekta Solutions AB | 2025-07-02 |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024-02-08 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | 2022-10-26 |
| K203250 | TaiChiC | Our United Corporation | 2021-03-12 |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | 2021-03-05 |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020-02-04 |
| K190844 | Akesis Galaxy | Akesis, Inc. | 2019-09-04 |
| K180571 | GammaPod | Xcision Medical Systems, LLC | 2018-04-04 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018-03-30 |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018-02-09 |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017-12-22 |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-04-20 |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015-10-29 |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015-08-04 |
| K150191 | GammaBeam 500 | Best Theratronics Limited | 2015-04-17 |
| K142219 | GammaBeam 100 | Best Theratronics Limited | 2014-11-13 |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2014-05-09 |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | 2014-02-28 |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2012-05-24 |
| K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | Masep Medical Science & Tech.Development (Shenzhen | 2011-03-22 |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Elekta Instrument AB | 2009-09-22 |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | 2007-03-05 |
| K061540 | LEKSELL GAMMAPLAN | Elekta Instrument AB | 2006-07-05 |
| K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | American Radiosurgery, Inc. | 2006-04-06 |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | Mds Nordion, Inc. | 2006-03-09 |
| K051022 | GAMMAPLAN | Elekta Instrument AB | 2005-06-01 |
| 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 |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | Mds Nordion | 2000-04-27 |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | Accuray, Inc. | 2000-04-19 |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | 1999-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860014221910 | Galaxy RTi | Akesis Inc. | 2026-05-11 |
| 06973682570151 | CybeRay | Our United Corporation | 2026-04-24 |
| 07340201503898 | Leksell GammaPlan | Elekta Solutions AB | 2026-02-04 |
| 07340048311786 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2021-03-28 |
| 07540180000238 | Clarity® | Elekta Solutions AB | 2020-06-19 |
| 07340048311878 | Leksell GammaPlan | Elekta Instrument AB | 2020-06-13 |
| 07540180000221 | Clarity® | Elekta Solutions AB | 2020-05-22 |
| 05060608880522 | ISORAD Detector, 1-4MV (-) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880584 | ISORAD Detector, 15-25MV (+) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880539 | ISORAD Detector, 1-4MV (+) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880546 | ISORAD Detector, 6-12MV (-) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880553 | ISORAD Detector, 6-12MV (+) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880560 | ISORAD Detector, 6-12MV (-) 1.5m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880577 | ISORAD Detector, 15-25MV (-) 3m | SUN NUCLEAR CORP. | 2019-05-21 |
| 05060608880591 | ISORAD Detector, 15-25MV (-) 1.5m | SUN NUCLEAR CORP. | 2019-05-21 |
| 07540180000207 | Clarity® | Elekta Ltd | 2018-11-19 |
| 07340048311588 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2018-09-16 |
| 07340048311229 | Leksell GammaPlan | Elekta Instrument AB | 2018-04-18 |
| 07540180000184 | Clarity® | Elekta Ltd | 2017-01-10 |
| 07340048305327 | Extend Frame system | Elekta Instrument AB | 2016-09-24 |
| 07340048304641 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-09-23 |
| 07540180000023 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000061 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000078 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000108 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000146 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000160 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07540180000177 | Clarity® | Elekta Solutions AB | 2016-09-23 |
| 07340048304627 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-09-23 |
| 07340048304573 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-09-23 |