Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5750](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5750) → IWB — System, Radiation Therapy, Radionuclide # IWB · System, Radiation Therapy, Radionuclide _Radiology · 21 CFR 892.5750 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB ## Overview - **Product Code:** IWB - **Device Name:** System, Radiation Therapy, Radionuclide - **Regulation:** [21 CFR 892.5750](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5750) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250391](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K250391.md) | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | Elekta Solutions AB | Jul 2, 2025 | SESE | | [K232854](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K232854.md) | Leksell GammaPlan (LGP) | Elekta Solutions AB | Feb 8, 2024 | SESE | | [K222047](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K222047.md) | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | Oct 26, 2022 | SESE | | [K203250](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K203250.md) | TaiChiC | Our United Corporation | Mar 12, 2021 | SESE | | [K203146](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K203146.md) | Akesis Galaxy RTi | Akesis, Inc. | Mar 5, 2021 | SESE | | [K200050](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K200050.md) | Akesis Galaxy RTx | Akesis, Inc. | Feb 4, 2020 | SESE | | [K190844](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K190844.md) | Akesis Galaxy | Akesis, Inc. | Sep 4, 2019 | SESE | | [K180571](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K180571.md) | GammaPod | Xcision Medical Systems, LLC | Apr 4, 2018 | SESE | | [K173789](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K173789.md) | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | Mar 30, 2018 | SESE | | [K173791](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K173791.md) | Leksell GammaPlan | Elekta Instrument AB | Feb 9, 2018 | SESE | | [K172706](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K172706.md) | GammaPod - Model A | Xcision Medical Systems, LLC | Dec 22, 2017 | SESE | | [K160440](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K160440.md) | Leksell Gamma Knife Icon | Elekta Instrument AB | Apr 20, 2016 | SESE | | [K151159](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K151159.md) | Leksell Gamma Knife Perfexion | Elekta Instrument AB | Oct 29, 2015 | SESE | | [K151561](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K151561.md) | Leksell Gamma Knife Icon | Elekta Instrument AB | Aug 4, 2015 | SESE | | [K150191](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K150191.md) | GammaBeam 500 | Best Theratronics Limited | Apr 17, 2015 | SESE | | [K142219](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K142219.md) | GammaBeam 100 | Best Theratronics Limited | Nov 13, 2014 | SESE | | [K133565](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K133565.md) | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 9, 2014 | SESE | | [K131777](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K131777.md) | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | Feb 28, 2014 | SESE | | [K120811](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K120811.md) | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 24, 2012 | SESE | | [K102533](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB/K102533.md) | ROTATING GAMMA SYSTEM INFINI (INFINI) | Masep Medical Science & Tech.Development (Shenzhen | Mar 22, 2011 | SESE | ## Top Applicants - Elekta Instrument AB — 13 clearances - Akesis, Inc. — 3 clearances - Elekta Solutions AB — 3 clearances - Theratronics, Inc. — 3 clearances - Accuray, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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