IWB · System, Radiation Therapy, Radionuclide
Radiology · 21 CFR 892.5750 · Class 2
Overview
| Product Code | IWB |
|---|---|
| Device Name | System, Radiation Therapy, Radionuclide |
| Regulation | 21 CFR 892.5750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB | Jul 2, 2025 | SESE |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | Feb 8, 2024 | SESE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | Oct 26, 2022 | SESE |
| K203250 | TaiChiC | Our United Corporation | Mar 12, 2021 | SESE |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | Mar 5, 2021 | SESE |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | Feb 4, 2020 | SESE |
| K190844 | Akesis Galaxy | Akesis, Inc. | Sep 4, 2019 | SESE |
| K180571 | GammaPod | Xcision Medical Systems, LLC | Apr 4, 2018 | SESE |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | Mar 30, 2018 | SESE |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | Feb 9, 2018 | SESE |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | Dec 22, 2017 | SESE |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | Apr 20, 2016 | SESE |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | Oct 29, 2015 | SESE |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | Aug 4, 2015 | SESE |
| K150191 | GammaBeam 500 | Best Theratronics Limited | Apr 17, 2015 | SESE |
| K142219 | GammaBeam 100 | Best Theratronics Limited | Nov 13, 2014 | SESE |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 9, 2014 | SESE |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Hyper Technology, Inc. | Feb 28, 2014 | SESE |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | Elekta Instrument AB | May 24, 2012 | SESE |
| K102533 | 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
