IWB — System, Radiation Therapy, Radionuclide Class II
FDA Device Classification
Classification Details
- Product Code
- IWB
- Device Class
- Class II
- Regulation Number
- 892.5750
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250391 | elekta solutions | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamm | July 2, 2025 |
| K232854 | elekta solutions | Leksell GammaPlan (LGP) | February 8, 2024 |
| K222047 | elekta solutions | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - E | October 26, 2022 |
| K203250 | our united corporation | TaiChiC | March 12, 2021 |
| K203146 | akesis | Akesis Galaxy RTi | March 5, 2021 |
| K200050 | akesis | Akesis Galaxy RTx | February 4, 2020 |
| K190844 | akesis | Akesis Galaxy | September 4, 2019 |
| K180571 | xcision medical systems | GammaPod | April 4, 2018 |
| K173789 | elekta instrument | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | March 30, 2018 |
| K173791 | elekta instrument | Leksell GammaPlan | February 9, 2018 |
| K172706 | xcision medical systems | GammaPod - Model A | December 22, 2017 |
| K160440 | elekta instrument | Leksell Gamma Knife Icon | April 20, 2016 |
| K151159 | elekta instrument | Leksell Gamma Knife Perfexion | October 29, 2015 |
| K151561 | elekta instrument | Leksell Gamma Knife Icon | August 4, 2015 |
| K150191 | best theratronics limited | GammaBeam 500 | April 17, 2015 |
| K142219 | best theratronics limited | GammaBeam 100 | November 13, 2014 |
| K133565 | elekta instrument | LEKSELL GAMMA KNIFE PERFEXION | May 9, 2014 |
| K131777 | hyper technology | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | February 28, 2014 |
| K120811 | elekta instrument | LEKSELL GAMMA KNIFE PERFEXION | May 24, 2012 |
| K102533 | masep medical science and tech.development (shenzhen | ROTATING GAMMA SYSTEM INFINI (INFINI) | March 22, 2011 |