IWB — System, Radiation Therapy, Radionuclide Class II
FDA product code IWB covers "System, Radiation Therapy, Radionuclide", a Class II medical device regulated under 21 CFR 892.5750. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |