Akesis Galaxy RTx
FDA 510(k) K200050 · Akesis, Inc.
510(k) numberK200050
Submission
- Device name
- Akesis Galaxy RTx
- Applicant
- Akesis, Inc.
Concord, CA, US - Received
- January 10, 2020
- Decision date
- February 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife®…IWB · Traditional | Elekta Solutions AB | 07/02/2025SE |
| K232854 | Leksell GammaPlan (LGP)IWB · Traditional | Elekta Solutions AB | 02/08/2024SE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…IWB · Traditional | Elekta Solutions AB | 10/26/2022SE |
| K203250 | TaiChiCIWB · Traditional | Our United Corporation | 03/12/2021SE |
| K203146 | Akesis Galaxy RTiIWB · Traditional | Akesis, Inc. | 03/05/2021SE |
| K190844 | Akesis GalaxyIWB · Traditional | Akesis, Inc. | 09/04/2019SE |
| K180571 | GammaPodIWB · Special | Xcision Medical Systems, LLC | 04/04/2018SE |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB · Traditional | Elekta Instrument AB | 03/30/2018SE |
| K173791 | Leksell GammaPlanIWB · Traditional | Elekta Instrument AB | 02/09/2018SE |
| K172706 | GammaPod - Model AIWB · Traditional | Xcision Medical Systems, LLC | 12/22/2017SE |
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Questions and answers
When was Akesis Galaxy RTx cleared by the FDA?
Akesis Galaxy RTx (K200050) received a 510(k) decision of Substantially Equivalent on February 4, 2020, 25 days after the submission was received.
What is the product code of K200050?
The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.